Events

LIFEPAK 1000 SYSTEM - DEFIBRILLATOR 의 리콜

Health Canada (via FOI)에 따르면, 해당 리콜 는 Canada 에서 WORKPLACE MEDICAL FIRST AID TRAINING 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
    25380
  • 사례 위험등급
    II
  • 사례 시작날짜
    2015-02-12
  • 사례 국가
    Canada
  • 사례 출처
    HC
  • 비고 / 경고
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • 데이터 추가 비고
  • 원인
    Physio-control has become aware of incidents where customers have attempted to use their lifepak 1000 defibrillator and the device has shut down unexpectedly due to a very low battery. a defibrillator in this scenario has the potential to fail to deliver a shock with the potential result that therapy is not delivered and a patient is not resuscitated. we have learned this to be as a result of batteries not being replaced when they have reached a low or very low state of charge as indicated in the readiness display on the device.

Device

LIFEPAK 1000 SYSTEM - DEFIBRILLATOR
  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: 99425-XXXXXX (Lot serial: all lots. contact mfg.)
  • 제품 설명
    LIFEPAK 1000 SYSTEM - DEFIBRILLATOR
  • Manufacturer
    WORKPLACE MEDICAL FIRST AID TRAINING

Manufacturer

WORKPLACE MEDICAL FIRST AID TRAINING
  • 제조사 주소
    HAMILTON
  • Source
    HC