• 제목/요약/키워드: Medical device failure

검색결과 74건 처리시간 0.023초

Temporary Right Ventricular Assist Device Insertion via Left Thoracotomy after Left Ventricular Assist Device Implantation

  • Park, Ilkun;Cho, Yang Hyun;Chung, Su Ryeun;Jeong, Dong Seop;Sung, Kiick;Kim, Wook Sung;Lee, Young Tak
    • Journal of Chest Surgery
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    • 제52권2호
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    • pp.105-108
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    • 2019
  • Right heart failure is a relatively common complication after left ventricular assist device (LVAD) implantation. Severe right heart failure can be managed by temporary right ventricular assist device (RVAD) implantation. However, trans-sternal RVAD insertion requires a subsequent third sternotomy for cannula removal. Herein, we present a case of RVAD insertion via a left anterior mini-thoracotomy after LVAD implantation in a patient with alcohol-induced cardiomyopathy.

종합병원 진단용방사선장비의 고장유형 분석 (Studies on Failure Kind Analysis of the Radiologic Medical Equipment in General Hospital)

  • 이우철;김정래
    • 대한방사선기술학회지:방사선기술과학
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    • 제22권2호
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    • pp.33-39
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    • 1999
  • This paper included a data analysis of the unit of medical devices using mainternance recording card that had medical devices of unit failure mode, hospital of failure mode and MTBF. The results of the analysis were as follows : 1. Medical devices of unit failure mode was the highest in QC/PM such A hospital as 33.9%, B hospital 30.9%, C hospital 30.3%, second degree was the Electrical and Electronic failure such A hospital as 23.5%, B hospital 25.3%, C hospital 28%, third degree was mechanical failure such A hospital as 19.5%, B hospital 22.5%, C hospital 25.4%. 2. Hospital of failure mode was the highest in Mobile X-ray device(A hospital 62.5%, B hospital 69.5%, C hospital 37.4%), and was the lowest in Sono devices(A hospital 16.76%, B hospital 8.4%, C hospital 7%). 3. Mean time between failures(MTBT) was the highest in SONO devices and was the lowest in Mobile X-ray devices which have 200 - 400 failure hours. 4. Anverage failure ratio was the highest in Mobile X-ray devices(A hospital 31.3%, B hospital 34.8%, C hospital 18.7%), and was the lowest in Sono(Ultrasound) devices (A hospital 8.4%, B hospital 4.2%, C hospital 3.5%). 5. Failure ratio results of medical devices according to QC/PM part of unit failure mode were as follows ; A hospital was the highest part of QC/PM (50%) in Mamo X-ray device and was the lowest part of QC/PM(26.4%) in Castro X-ray. B hospital was the highest part of QC/PM(56%) in Mobile X-ray device, and the lowest part of QC/PM(12%) in Gastro X-ray. C hospital was the highest part of QC/PM(60%) in R/F X-ray device, and the lowest a part of QC/PM(21%) in Universal X-ray. It was found that the units responsible for most failure decreased by systematic management. We made the preventive maintenance schedule focusing on adjustement of operating and dust removal.

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ISO14971 기반 FMEA를 이용한 중환자실내 인공호흡기 신뢰성 관리 (Reliability Management of Mechanical Ventilator in Intensive Care Unit Using FMEA Based on ISO14971)

  • 김현준;김원규;김태종;서지영
    • 대한의용생체공학회:의공학회지
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    • 제44권1호
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    • pp.19-24
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    • 2023
  • Due to the spread of COVID-19, many patients with severe respiratory diseases have occurred worldwide, and accordingly, the use of mechanical ventilators has exploded. However, hospitals do not have systematic risk management, and the Medical Device Regulation also provides medical device risk management standards for manufacturers, but does not apply to devices in use. In this paper, we applied the Failure Mode Effects Analysis (FMEA) risk analysis technique based on the International Standard ISO 14971 (Medical Devices-Application of risk management to medical devices) for 85 mechanical ventilators of a specific model in use in hospitals. Failure modes and effects of each parts were investigated, and risk priority was derived through multiplication of each score by preparing criteria for severity, occurrence, and detection for each failure mode. As a result, it was confirmed that the microprocessor-based Patient Unit/Monitoring board in charge of monitoring scored the highest score with 36 points, and that reliability management is possible through systematic risk management according to priority.

심실의 부하감소 측면에서 좌심실 보조장치의 최적 치료시기 예측을 위한 시뮬레이션 연구 (Prediction of Pumping Efficacy of Left Ventricular Assist Device according to the Severity of Heart Failure: Simulation Study)

  • 김은혜;임기무
    • 한국기계가공학회지
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    • 제12권4호
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    • pp.22-28
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    • 2013
  • It is important to begin left ventricular assist device (LVAD) treatment at appropriate time for heart failure patients who expect cardiac recovery after the therapy. In order to predict the optimal timing of LVAD implantation, we predicted pumping efficacy of LVAD according to the severity of heart failure theoretically. We used LVAD-implanted cardiovascular system model which consist of 8 Windkessel compartments for the simulation study. The time-varying compliance theory was used to simulate ventricular pumping function in the model. The ventricular systolic dysfunction was implemented by increasing the end-systolic ventricular compliance. Using the mathematical model, we predicted cardiac responses such as left ventricular peak pressure, cardiac output, ejection fraction, and stroke work according to the severity of ventricular systolic dysfunction under the treatments of continuous and pulsatile LVAD. Left ventricular peak pressure, which indicates the ventricular loading condition, decreased maximally at the 1st level heart-failure under pulsatile LVAD therapy and 2nd level heart-failure under continuous LVAD therapy. We conclude that optimal timing for pulsatile LVAD treatment is 1st level heart-failure and for continuous LVAD treatment is 2nd level heart-failure when considering LVAD treatment as "bridge to recovery".

ENGINEERING A BIOARTIFICIAL LIVER DEVICE

  • 박재성
    • 대한기계학회:학술대회논문집
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    • 대한기계학회 2008년도 추계학술대회A
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    • pp.1419-1426
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    • 2008
  • Fulminant hepatic failure is a clinical syndrome associated with a high mortality rate. Orthotopic liver transplantation is the only clinically proven effective treatment for patients with end-stage liver disease who do not respond to medical management. A major limitation of this treatment modality is the scarcity of donor organs available, resulting in patients dying while waiting for a donor liver. An extracorporeal bioartificial liver (BAL) device containing viable hepatocytes has the potential to provide temporary hepatic support to liver failure patients, serving as a bridge to transplantation while awaiting a suitable donor. In some patients, providing temporary hepatic support may be sufficient to allow adequate regeneration of the host liver, thereby eliminating the need for a liver transplant. Although the BAL device is a promising technology for the treatment of liver failure, there are several technical challenges that must be overcome in order to develop systems with sufficient processing capacity and of manageable size. In this overview, the authors describe the critical issues involved in developing a BAL device. They also discuss their experiences in hepatocyte culture optimization within the context of a microchannel flat-plate BAL device.

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Bridge to Transplantation with a Left Ventricular Assist Device

  • Jung, Jae-Jun;Sung, Ki-Ick;Jeong, Dong-Seop;Kim, Wook-Sung;Lee, Young-Tak;Park, Pyo-Won
    • Journal of Chest Surgery
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    • 제45권2호
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    • pp.116-119
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    • 2012
  • A 61-year-old female patient was diagnosed with dilated cardiomyopathy with severe left ventricle dysfunction. Two days after admission, continuous renal replacement therapy was performed due to oliguria and lactic acidosis. On the fifth day, an intra-aortic balloon pump was inserted due to low cardiac output syndrome. Beginning 4 days after admission, she was supported for 15 days thereafter with an extracorporeal left ventricular assist device (LVAD) because of heart failure with multi-organ failure. A heart transplant was performed while the patient was stabilized with the LVAD. She developed several complications after the surgery, such as cytomegalovirus pneumonia, pulmonary tuberculosis, wound dehiscence, and H1N1 infection. On postoperative day 19, she was discharged from the hospital with close follow-up and treatment for infection. She received follow-up care for 10 months without any immune rejection reaction.

Urosepsis and postrenal acute renal failure in a neonate following circumcision with Plastibell device

  • Kalyanaraman, Meena;McQueen, Derrick;Sykes, Joseph;Phatak, Tej;Malik, Farhaan;Raghava, Preethi S.
    • Clinical and Experimental Pediatrics
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    • 제58권4호
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    • pp.154-157
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    • 2015
  • Plastibell is one of the three most common devices used for neonatal circumcision in the United States, with a complication rate as low as 1.8%. The Plastibell circumcision device is commonly used under local anesthesia for religious circumcision in male neonates, because of cosmetic reasons and ease of use. Occasionally, instead of falling off, the device may get buried under the skin along the shaft of the penis, thereby obstructing the normal flow of urine. Furthermore, the foreskin of neonates is highly vascularized, and hence, hemorrhage and infection are possible when the skin is cut. Necrosis of penile skin, followed by urethral obstruction and renal failure, is a serious surgical mishap requiring immediate corrective surgery and medical attention. We report a case of fulminant urosepsis, acute renal failure, and pyelonephritis in a 4-day-old male neonate secondary to impaction of a Plastibell circumcision device. Immediate medical management was initiated with fluid resuscitation and mechanical ventilation; thereby correcting life threatening complications. Pediatricians and Emergency Department physicians should be cognizant of the complications from Plastibell circumcision device in order to institute appropriate and timely management in neonates.

Surgical Outcomes of Centrifugal Continuous-Flow Implantable Left Ventricular Assist Devices: Heartmate 3 versus Heartware Ventricular Assist Device

  • Kinam Shin;Won Chul Cho;Nara Shin;Hong Rae Kim;Min-Seok Kim;Cheol Hyun Chung;Sung-Ho Jung
    • Journal of Chest Surgery
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    • 제57권2호
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    • pp.184-194
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    • 2024
  • Background: Left ventricular assist devices (LVADs) are widely employed as a therapeutic option for end-stage heart failure. We evaluated the outcomes associated with centrifugal-flow LVAD implantation, comparing 2 device models: the Heartmate 3 (HM3) and the Heartware Ventricular Assist Device (HVAD). Methods: Data were collected from patients who underwent LVAD implantation between June 1, 2015 and December 31, 2022. We analyzed overall survival, first rehospitalization, and early, late, and LVAD-related complications. Results: In total, 74 patients underwent LVAD implantation, with 42 receiving the HM3 and 32 the HVAD. A mild Interagency Registry for Mechanically Assisted Circulatory Support score was more common among HM3 than HVAD recipients (p=0.006), and patients receiving the HM3 exhibited lower rates of preoperative ventilator use (p=0.010) and extracorporeal membrane oxygenation (p=0.039). The overall early mortality rate was 5.4% (4 of 74 patients), with no significant difference between groups. Regarding early right ventricular (RV) failure, HM3 implantation was associated with a lower rate (13 of 42 [31.0%]) than HVAD implantation (18 of 32 [56.2%], p=0.051). The median rehospitalization-free period was longer for HM3 recipients (16.9 months) than HVAD recipients (5.3 months, p=0.013). Furthermore, HM3 recipients displayed a lower incidence of late hemorrhagic stroke (p=0.016). In the multivariable analysis, preoperative use of continuous renal replacement therapy (odds ratio, 22.31; p=0.002) was the only significant predictor of postoperative RV failure. Conclusion: The LVAD models (HM3 and HVAD) demonstrated comparable overall survival rates. However, the HM3 was associated with a lower risk of late hemorrhagic stroke.

Transfromation of Percutaneous Extracorporeal Life Support to Paracorporeal Ventricular Assist Device: A Case Report

  • Kim, Chilsung;Cho, Yang Hyun;Sung, Kiick;Yang, Ji-Hyuk
    • Journal of Chest Surgery
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    • 제47권4호
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    • pp.409-412
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    • 2014
  • Percutaneous extracorporeal life support (P-ECLS) is a useful modality for the management of refractory cardiac or pulmonary failure. However, venoarterial P-ECLS may result in a complication of left ventricular distension. In this case report, we discuss a patient with drug-induced dilated cardiomyopathy managed with venoarterial P-ECLS and a left atrial vent catheter. The venoarterial P-ECLS was modified to a paracorporeal left ventricular assist device (LVAD) by removing the femoral venous cannula. After 28 days of hospitalization, the patient was successfully weaned from the paracorporeal LVAD and discharged home from the hospital.

국산 의료기기 사용률과 사용자 및 관리자 인식 조사를 통한 국산 의료기기 개선 방안 (Suggest Improvement for Medical Device Made in Korea by the Investigation of Domestic Medical Device Percentage and Survey of Medical Device Users and Manager)

  • 이정현
    • 재활복지공학회논문지
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    • 제11권4호
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    • pp.299-306
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    • 2017
  • 국산 의료기기 산업에 대한 다양한 투자와 신기술 도입에 따라 국내의료기기 산업은 비약적인 증가를 하고 있으나 국내 대형의료기관의 국산의료기기 사용률은 여전히 저조한 것으로 조사되고 있다. 본 논문에서는 국내 대형병원에서의 국산 의료기기 사용률과 사용자 및 관리자의 인식조사를 수행하여 국산의료기기의 개선점을 제시하였다. 이를 위해 국내 4곳의 국립대학교병원을 대상으로 전체 의료기기의 종류와 국산 의료기기 사용률에 대한 조사를 진행하고 이를 바탕으로 의료기기 중 중점조사 대상 의료기기를 선정하였다. 중점조사대상 의료기를 대상으로 고장통계와 사용자 인식조사를 수행하였으며 이를 통해 중점조사대상 의료기기의 개선사항을 제시하였다.