Events

V60 Non Invasive Ventilators (adult mechanical ventilator) 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-2012-RN-00930-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2012-09-11
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00930-1
  • 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
    A review of manufacturing data found that certain blower motor assemblies in the affected v60 ventilators may not meet specifications. specifically, the impeller may not be properly seated on the blower motor shaft. this could subsequently cause the blower to cease functioning which would result in the failure of the v60 ventilator to deliver therapy to the patient due to the loss of ventilation. the v60 ventilator will alert users to malfunctioning blowers through audible and visual alarms.
  • 조치
    Mayo Healthcare is replacing all affected blower motors.

Device

V60 Non Invasive Ventilators (adult mechanical ventilator)
  • 모델명 / 제조번호(시리얼번호)
    V60 Non Invasive Ventilators (adult mechanical ventilator)Serial Numbers: 100029455, 100030106, 100030107, 100020111, 100030112, 100030113, 100030115, 100030117, 100030118, 100030120 & 100030121ARTG Number: 134845
  • 의료기기 분류등급
    Anesthesiology Devices
  • Manufacturer
    Mayo Healthcare Pty Ltd

Manufacturer

Mayo Healthcare Pty Ltd