Events

V60 Non-invasive Ventilators 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Mayo Healthcare 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-00625-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2013-06-18
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00625-1
  • 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
    In the rare even a component fails due to a software issue, the following sequence of events may occur:1) power management board assembly (pmba) vmain shorts to ground,2) the ventilator shuts down,3) the software repeatedly cycles through part of its initialisation sequence and power on self test (post), the alarm may not sound to indicate that ventilation therapy has ceased.
  • 조치
    The V60 ventilator may continue to be used in accordance with its directions for use. A Mayo healthcare representative will be contacting users to schedule the corrective action to upgrade the software. A loan unit will be provided to the users until the corrective action is completed.

Device

V60 Non-invasive Ventilators

Manufacturer

Mayo Healthcare Pty Ltd