Events

Philips HeartStart MRx Monitor/Defibrillator 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Philips Medical Systems (USA) 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
    17845
  • 사례 시작날짜
    2014-12-10
  • 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: Philips New Zealand Commercial Limited, Level 3, 123 Carlton Gore Road, Newmarket, AUCKLAND 1023
  • 원인
    The mrx can be susceptible to one or both of the issues described below., 1. the co2 inlet port associated with end-tidal carbon dioxide (etco2) monitoring on mrx monitor/defibrillators can be pushed into the mrx housing, making it inaccessible. this can occur if the user attempts to push the co2 filterline fitting into the inlet port, instead of twisting it clockwise as described in the mrx instructions for use., 2. the handle can separate from the mrx housing due to breakage of mounts on the rear case.
  • 조치
    Product to be modified

Device

Philips HeartStart MRx Monitor/Defibrillator
  • 모델명 / 제조번호(시리얼번호)
    Model: Models: M3535A & 3536A, Affected: Serial Numbers: US00100100 to US00552845 (M3535A) & US00100902 to US00552848 (M3536A)
  • Manufacturer
    Philips Medical Systems (USA)

Manufacturer

Philips Medical Systems (USA)
  • 제조사 모회사 (2017)
    Philips
  • Source
    NZMMDSA