Events

Cardiac Science Powerheart G5 Automated External Defibrillators 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Cardiac Science Inc 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
    16198
  • 사례 시작날짜
    2014-02-19
  • 사례 국가
    New Zealand
  • 사례 출처
    NZMMDSA
  • 사례 출처 URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • 비고 / 경고
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • 데이터 추가 비고
    Recalling Organisation: REM Systems Limited, 69 Elizabeth Knox Place, Glen Innes, AUCKLAND
  • 원인
    Cardiac science has determined certain powerheart g5 automatic external defibrillators (aeds) shipped between june 21, 2012, and march 1, 2013, may have been manufactured with a defective electrode connector. some of these g5 aeds have been found with missing spring contacts in the electrode connector assembly. when the spring is missing, the aed may not recognise that the pads have been placed on the patient during a rescue attempt. the aed voice prompts will progress until they reach the pads placement (peeled) step. at that point the aed will, regardless of whether the pads are placed onto the patient's chest or not, continuously repeat "place pads firmly onto patient's chest..." after 2 minutes, the pad placement prompting will time out and the aed will begin cpr mode. if the issue occurs, the aed may not be able to deliver therapy during a rescue attempt and may affect resuscitation of the patient. this could lead to serious adverse health events or death.
  • 조치
    Product to be modified

Device

Cardiac Science Powerheart G5 Automated External Defibrillators
  • 모델명 / 제조번호(시리얼번호)
    Model: Model: G5A-31A, Affected:
  • Manufacturer
    Cardiac Science Inc

Manufacturer

Cardiac Science Inc