Events

SLE 5000 Ventilator 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 AHC Solutions Pty Ltd 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    RC-2013-RN-00855-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2013-08-23
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00855-1
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • 데이터 추가 비고
  • 원인
    The manufacturer has identified a potential risk associated with the fp110-410 psu (power supply unit). their internal monitoring and investigations have identified a suspect batch of electrolytic capacitors used on the main pcb (printed circuit board) of the 410 power supply unit. the affected capacitors may exhibit a swelling that if not replaced, may in time cause the ventilator to shut down during normal operation. please note that should the ventilator shut down, a total power fail alarm will sound.
  • 조치
    AHC Solutions is advising users to identify ventilators with serial numbers below 53164 and, using the instructions provided, identify ventilators with Power Supply Units with serial numbers between 163746 to 167558 for replacement.

Device

SLE 5000 Ventilator
  • 모델명 / 제조번호(시리얼번호)
    SLE 5000 VentilatorVentilator model SLE 5000: Serial numbers below 53164Power supply unit model FP110-410: Serial numbers 163746 to 167558 inclusiveARTG Number: 114000
  • Manufacturer
    AHC Solutions Pty Ltd

Manufacturer

AHC Solutions Pty Ltd