• Title/Summary/Keyword: Medical device failure

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Unexpected Restart Failure of Durable Left Ventricular Assist Devices: A Report of Two Cases

  • Hyo Won Seo;Ga Hee Jeong;Sung Min Kim;Minjung Bak;Darae Kim;Jin-Oh Choi;Kiick Sung;Yang Hyun Cho
    • Journal of Chest Surgery
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    • v.57 no.3
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    • pp.315-318
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    • 2024
  • The HeartWare Ventricular Assist Device (HVAD) was widely used for mechanical circulatory support in patients with end-stage heart failure. However, there have been reports of a critical issue with HVAD pumps failing to restart, or experiencing delays in restarting, after being stopped. This case report describes 2 instances of HVAD failure-to-restart during heart transplantation surgery and routine outpatient care. Despite multiple attempts to restart the pump using various controllers and extensions, the HVAD failed to restart, triggering a hazard alarm for pump stoppage. In one case, the patient survived after receiving a heart transplantation, while in the other, the patient died immediately following the controller exchange. These cases highlight the rare but life-threatening complication of HVAD failure-to-restart, underscoring the importance of awareness among clinicians, patients, and caregivers, and adherence to the manufacturer's guidelines and recommendations for HVAD management.

Surface Tribology of Total Ankle Joint Replacement (인공발목관절의 표면 마모 특성)

  • Jeong, Yong-Hoon;Jung, Tae-Gon;Yang, Jae-Woong;Park, Kwang-Min;Lee, Su-Won
    • Proceedings of the Korean Institute of Surface Engineering Conference
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    • 2016.11a
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    • pp.117-117
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    • 2016
  • Total ankle replacement (TAR) is a visible option in the surgical treatment of degenerative or inflammatory diseases of ankle joint. it is attributed to the current TAR which has improvements in surgical technique, uncemented implant fixation and minimally constrained articulation. In the clinical result, they can show promised surgical result when compared to earlier attempts in TAR. However, TAR is still not as successful as total knee replacement (TKR) or total hip replacement (THR), it needs to be note that there are limitations in concerning of long term performance of TAR, the high failure rate still associated with wear of the PE (polyethylene) component that has related with their material property and surface roughness. The aim of this study was to introduce the tribology characteristics of total ankle joint prosthesis with one of TDR model which was fabricated to try multi-axis wear test as a region of motion in ankle joint. The wear specimen of TDR was prepared with Ti-6Al-4V alloy and UHMWPE (ultra-high molecular weight polyethylene) for tibia-talus and bearing component, respectively. A wear test was carried out using a Force 5 (AMTI, Massachusetts, US) wear simulator which can be allowed to move in three axis to flexion-extension ($+3^{\circ}{\sim}-6^{\circ}$), internal-external axial rotation (${\pm}5^{\circ}$), as well as sinusoidal compressive load (1.6 kN, R=10). All tests were performed following standard ISO 14243, wear rate was calculated with weight loss of UHMWPE bearing while the specimen has tested at certain cycles. As based on the preliminary results, wear rate of UHMWPE bearing was $7.9{\times}10^{-6}mg/cycles$ ($R^2=0.86$), calculated loss weight until $10^7cycles$ was 79 mg, respectively.

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Association of Congestive Heart Failure and Death with Ankylosing Spondylitis : A Nationwide Longitudinal Cohort Study in Korea

  • Bae, Ki Hwan;Hong, Je Beom;Choi, Yoon Jin;Jung, Jin Hyung;Han, In-Bo;Choi, Jung Min;Sohn, Seil
    • Journal of Korean Neurosurgical Society
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    • v.62 no.2
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    • pp.217-224
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    • 2019
  • Objective : We attempted to discover that Ankylosing spondylitis (AS) has a comprehensive relationship with congestive heart failure and death. Methods : We used a nationwide database managed by the Korean National Health Insurance Service from 2010 to 2014. Twelve thousand nine hundred eighty-eight patients with a diagnosis of AS and 64940 age- and sex- stratified matching subjects without AS were enrolled in the AS and control groups. Incidence probabilities of 6 years congestive heart failure and death in each group were calculated. The Cox proportional hazard regression analysis was used to estimate the hazard ratio. We divided the AS and control groups into subgroups according to sex, age, income, and comorbidities. Results : During the follow-up period, 102 patients (0.79%) in the AS group and 201 patients (0.32%) in the control group developed congestive heart failure (p<0.0001). In addition, 211 (1.62%) subjects in the AS group died during the follow-up period compared to 639 (0.98%) subjects in the control group (p<0.0001). The adjusted hazard ratio of congestive heart failure and death in the AS group was 2.28 (95% confidence interval [CI], 1.80-2.89) and 1.66 (95% CI, 1.42-1.95), respectively. The hazard ratios of congestive heart failure and death were significantly increased in all of the subgroups. Conclusion : The incidence rates of congestive heart failure and death were increased in AS patients.

Intensive management of acute right heart failure (급성 우심 부전의 집중 치료)

  • Kim, Gi Beom;Noh, Chung Il
    • Clinical and Experimental Pediatrics
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    • v.50 no.11
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    • pp.1041-1048
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    • 2007
  • Not a few patients in children and adolescents are suffering from right ventricular (RV) dysfunction resulting from various conditions such as chronic lung disease, left ventricular dysfunction, pulmonary hypertension, or congenital heart defect. The RV is different from the left ventricle in terms of ventricular morphology, myocardial contractile pattern and special vulnerability to the pressure overload. Right ventricular failure (RVF) can be evaluated in terms of decreased RV contractility, RV volume overload, and/or RV pressure overload. The management for RVF starts from clear understanding of the pathophysiology of RVF. In addition to correction of the underlying disease, management of RVF per se is very important. Meticulous control of volume status, inotropic agents, vasopressors, and pulmonary selective vasodilators are the main tools in the management of RVF. The relative importance of each tool depends on the individual clinical status. Medical assist device and surgery can be considered selectively in case of refractory RVF to optimal medical treatment.

Mechanical Stability of TiN and DLC Coated Instrument of Pedicle Screw System (TiN 및 DLC 코팅된 척추경나사못시스템 수술기구의 기계적 안정성 분석)

  • Kang, Kwan-Su;Jung, Tae-Gon;Yang, Jae-Woong;Woo, Su-Heon;Park, Tea-Hyun;Jeong, Yong-Hoon
    • Journal of the Korean institute of surface engineering
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    • v.52 no.3
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    • pp.163-170
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    • 2019
  • Durability of instrument is one of the most important factor to ensure accurate treatment and decrease failure for the orthopedic surgical operation. Normally, a set-screw driver tip has been processed with hard coating for their higher durability and wear resistance. And several surface modification methods were obtained such as titanium nitride (TiN) coating, diamond like carbon coating, other nitriding, and etc. In this study, we have surface modified on set-screw driver tip with TiN and DLC, investigated whether the TiN and DLC coatings affect the mechanical properties and durability of the set-screw driver tip in the pedicle screw system. The surface morphologies were observed with scanning-electron microscopy (SEM), and the static/dynamic torsional properties were investigated with universal testing machine based on ASTM F543. Coating thickness of each coatings were commonly around $1^{\circ}C$. Static torsional stiffness, and ultimate torque values for DLC and TiN coated samples were significantly higher than those of non-coated sample by the pared T-test. Surface morphology of after the dynamic torsional test was more clean with less scratch or friction traces from DLC coating than that of TiN coating and non-coated sample.

The Data Transmission of Image Storage System of PACS (PACS내 영상저장 장치의 데이터 전송)

  • Cho, EuyHyun;Park, Jeongkyu
    • Journal of the Korean Society of Radiology
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    • v.12 no.6
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    • pp.785-791
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    • 2018
  • Recently, Disk array is widely used as a long term storage device in PACS, but reliability is not enough in relation to annual failure rate of disk. Between October 2016 and February 2017, we scanned the serial port of the hard disk while reading or storing medical images on a PACS reader. The data rate was calculated from the data stored in HDD 99ea that were used in the PCAS image storage device and in HDD 101ea that were used in the Personal Computer. When a CT image was read from a PACS reader, Reading was 87.8% and Writing was 12.2% in units of several tens of megabytes or less. When the CT image was stored in the PACS reader, Reading was 11.4% and Writing was 88.6% in units of several tens of megabytes or less. While reading the excel file on the personal computer, Reading was 75% and Writing was 25% in less than 3 MB, and In the process of storing the excel file on the personal computer, Reading was carried out by 38% and Writing was carreid out 62% in the units of 3 MB or less. The transfer rate of the hard disk used in the PACS image storage device was 10 GB/h, and the transfer rate per hour of the hard disk of the personal computer was 5 GB / h. Annual failure rate of hard disk of image storage system is 0.97 ~ 1.13%, Annual failure rate of Hard Disk of personal computer is 0.97 ~ 1.13%. the higher transfer rate is, the higher annual failure rate is. These results will be used as a basis for predicting the life expectancy of the hard disk and the annual failure rate.

A Study on Development of 2MHz High-frequency Rehabilitation Treatment Device for Deep Part (심부투열용 2MHz 고주파 재활치료기의 개발에 관한 연구)

  • Ahn, Jong-Bok;Kim, Sang-Beom;Won, Cheol-Hee;Kim, Sung-Hoon;Park, Chul-Won
    • The Transactions of the Korean Institute of Electrical Engineers P
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    • v.66 no.3
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    • pp.117-122
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    • 2017
  • Due to the aging and obesity population in Korea, degenerative musculoskeletal diseases and people suffering from degenerative arthritis are increasing day by day. So, it is necessary to develop rehabilitation treatment device. Conventional high-frequency treatment devices have disadvantages in that therapeutic range is narrow, cost is high, image is adversely affected, treatment time is long, and failure rate is high. This paper proposes a customized therapy device that is stable and effective in reducing treatment time and output to target body part using 2MHz switching frequency, feedback control technique, and joint insulation flexible multipolar electrode. The device can be a new concept high-frequency stimulator to accommodate the advantages of CET and RET.

Multi-modal Wearable Device for Cardiac Arrest Detection (심정지 감지를 위한 다생체 신호 측정 웨어러블 디바이스 개발)

  • Ahn, Hyun Jun;You, Sung Min;Cho, Kyeongwon;Park, Hoon Ki;Kim, In Young
    • Journal of Biomedical Engineering Research
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    • v.38 no.6
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    • pp.330-335
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    • 2017
  • Cardiac arrest is owing to the failure of the heart that makes the blood circulation stop. Arrested blood circulation prevents the supply of the oxygen and the glucose and it results the loss of consciousness and, finally, brain death. Many public institution installed the AED for emergency treatment, but, it is not efficient when the patient is alone. In this paper, we made multiplexed wearable device for cardiac arrest detection. With this device, we measure the individual's electrocardiography, heart sound and motion. If the cardiac arrest is detected, the device make a warning horn and transmit the signal for defibrillation. We obtain 98.33% of ECG data, 94.5% of PCG data and 98.38% of IMU data accuracy for each evaluation and 93.33% accuracy for integrated evaluation.

Outcomes of transcatheter closure of ductus arteriosus in infants less than 6 months of age: a single-center experience

  • Choi, Gwang-Jun;Song, Jinyoung;Kim, Yi-Seul;Lee, Heirim;Huh, June;Kang, I-Seok
    • Clinical and Experimental Pediatrics
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    • v.61 no.12
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    • pp.397-402
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    • 2018
  • Purpose: Transcatheter device closure of patent ductus arteriosus (PDA) is challenging in early infancy. We evaluated PDA closure in infants less than 6 months old. Methods: We performed a retrospective review of infants less than 6 months of age who underwent attempted transcatheter device closure in our institution since 2004. To compare clinical outcomes between age groups, infants aged 6-12 months in the same study period were reviewed. Results: A total of 22 patients underwent transcatheter PDA closure during the study period. Patient mean age was $3.3{\pm}1.5months$, and weight was $5.7{\pm}1.3kg$. The duct diameter at the narrowest point was $3.0{\pm}0.8mm$ as measured by angiography. The most common duct type was C in the Krichenko classification. Procedural success was achieved in 19 patients (86.3%). Major complications occurred in 5 patients (22.7%), including device embolization (n=1), acquired aortic coarctation (n=2), access-related vascular injury requiring surgery (n=1), and acute deterioration requiring intubation during the procedure (n=1). Two patients had minor complications (9.1%). Twenty-four infants aged 6-12 months received transcatheter device closure. The procedural success rate was 100%, and there were no major complications. The major complication rate was significantly higher in the group less than 6 months of age (P=0.045). There was a trend toward increased major complication and procedural failure rates in the younger age group (P<0.01). Conclusion: A relatively higher incidence of major complications was observed in infants less than 6 months of age. The decision regarding treatment modality should be individualized.

HeartMate 3 Implantation via Only Left Thoracotomy: A Case Report

  • Mi Young Jang;Jun Ho Lee;Su Ryeun Chung;Kiick Sung;Wook Sung Kim;Yang Hyun Cho
    • Journal of Chest Surgery
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    • v.56 no.3
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    • pp.224-227
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    • 2023
  • Median sternotomy is a standard surgical technique used for left ventricular assist device (LVAD) implantation. However, if sternotomy has a prohibitive surgical risk, LVAD implantation can be performed through only left thoracotomy. We managed a patient with end-stage heart failure who had recently undergone coronary artery bypass grafting (CABG) elsewhere. The patient also had a deep sternal wound infection and bacteremia. Because of refractory cardiogenic shock, we performed extracorporeal membrane oxygenation (ECMO). After multiple mediastinal washouts and omental flap placement, ECMO was converted to extracorporeal LVAD (from the left ventricular apex to the descending aorta) through a left thoracotomy. The extracorporeal LVAD was maintained for 18 days and replaced by the HeartMate 3 LVAD. The patient was discharged in good condition 115 days after CABG.