Events

Samaritan PDU 400 (automated external defibrillator) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Aero Healthcare 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-2014-RN-00089-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-02-03
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00089-1
  • 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 software of samaritan pdu 400 devices may fail to accurately determine the remaining capacity of the device battery. rather than emitting an alarm warning the user that the device has insufficient battery to deliver therapy the device may shut down. in such circumstances, an affected device may be unable to operate during a sudden cardiac arrest.This action was undertaken prior to the agreement of the communication by the tga.
  • 조치
    Areo Healthcare provided replacement PDU 400 devices to all affected customers.

Device

Samaritan PDU 400 (automated external defibrillator)
  • 모델명 / 제조번호(시리얼번호)
    Samaritan PDU 400 (automated external defibrillator)Serial Numbers between 08P00001003 to 11P00007347
  • Manufacturer
    Aero Healthcare

Manufacturer

Aero Healthcare