Weinmann Medumat Transport Ventilator 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Maquet Australia 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-01126-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2013-11-01
  • 사례 국가
  • 사례 출처
    DHTGA
  • 사례 출처 URL
  • 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, weinmann emergency, has identified a potential issue that could result in an undefined operating state of the medumat transport ventilator. in some cases an interaction between internal structural components and sensors for internal device monitoring can cause an undefined operating state resulting in the device displaying a "device malfunction" error.
  • 조치
    Maquet is advising users to switch the machine off and on again in the case of the error message "device malfunction". This will suspend running ventilation for approximately 30 seconds. Maquet is providing a software update to eliminate incorrect "Device Malfunction" errors. Users should note that any "Device Malfunction" errors after the installation of the software update are valid.

Device

  • 모델명 / 제조번호(시리얼번호)
    Weinmann Medumat Transport VentilatorAll serial numbersARTG Number: 190246
  • Manufacturer

Manufacturer