Events

Philips Heartstart MRx Monitor/Defib 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
    13427
  • 사례 시작날짜
    2012-08-31
  • 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: Laerdal (New Zealand) Ltd, Unit O, Cain Commerical Centre, 20 Cain Road, Penrose
  • 원인
    Certain heartstart mrx monitor/defibrillators were manufactured with compromised components within the time frames of july 12, 2011 through september 2, 2011 and january 19, 2012 through may 22, 2012., may present the folowing behaviours:, a. in aed mode the mrx experiences difficulty interpreting pads ecg waveforms and may incorrectly analyze the waveform (potential for inappropriate therapy) or fail to anlyze the waveform., b. in manual mode the user may have trouble interpreting the pads ecg waveform and determining whether or not to deliver therapy. in addition the mrx may provide erroneous alarms or indicate an asystolic rhythm when paddles are not in patient cntact., c. if cpr meter is in use, users may not get an accurate impedance derived ventilation feedback.
  • 조치
    Product to be modified

Device

Philips Heartstart MRx Monitor/Defib
  • 모델명 / 제조번호(시리얼번호)
    Model: M3535A, M3536A, M3536M4, M3536M5, M3536M6, Affected: Multiple
  • Manufacturer
    Philips Medical Systems (USA)

Manufacturer

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