• Journal of Chest Surgery
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• v.52 no.2
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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.

• Journal of radiological science and technology
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• v.22 no.2
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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.

• Journal of Biomedical Engineering Research
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• v.44 no.1
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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.

• Journal of the Korean Society of Manufacturing Process Engineers
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• v.12 no.4
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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".

• Proceedings of the KSME Conference
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• 2008.11a
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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.

• Journal of Chest Surgery
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• v.45 no.2
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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.

• Clinical and Experimental Pediatrics
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• v.58 no.4
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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.

• Journal of Chest Surgery
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• v.57 no.2
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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.

• Journal of Chest Surgery
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• v.47 no.4
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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.

• Journal of rehabilitation welfare engineering & assistive technology
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• v.11 no.4
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• pp.299-306
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• 2017

The Korean medical device industry has increased dramatically due to various investments in the domestic medical device industry and the introduction of new technologies, but the domestic medical device usage rate in great hospital is still low. In this paper, improvement point for domestic medical device was suggested by domestic medical device usage rate and user and manager's perception survey in great hospitals in Korea. To do this, a survey on the types of medical devices and domestic medical device usage rates were conducted at four national university hospitals in Korea. From this results, the priority survey medical devices were selected. Improvements of Korean medical devices were suggested by failure mode analysis and user awareness surveys for the priority survey medical devices.