Events

LIFEPAK 20 and LIFEPAK 15 Manual Defibrillator 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Physio-Control Corporation 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
    21164
  • 사례 시작날짜
    2017-03-03
  • 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: Medxus Ltd, Unit 4, 100 Fitgerald Avenue, Christchurch 8011
  • 원인
    During the investigation the manufacturer of the etco2 module found that compressed air may have contaminated filters within in the etco2 module. as a result of the contamination of the filter, the etco2 display on the lifepak 15 will provide a reading of xxx. there may be solid or dashed lines present on the device display in the place of an etco2 waveform and the service led will be illuminated. in this situation the etco2 monitoring functionality will no longer be available.
  • 조치
    Product to be exchanged

Device

LIFEPAK 20 and LIFEPAK 15 Manual Defibrillator
  • 모델명 / 제조번호(시리얼번호)
    Model: , Affected: LIFEPAK 15 Monitor/Defibrillator with End-Tidal CO2 option.
  • Manufacturer
    Physio-Control Corporation

Manufacturer

Physio-Control Corporation
  • 제조사 모회사 (2017)
    Stryker
  • Source
    NZMMDSA