Events

Philips HeartStart MRx Monitor/Defibrillator 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Philips Electronics Australia Ltd 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
    RC-2014-RN-00236-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2014-02-27
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00236-1
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • 데이터 추가 비고
  • 원인
    The ecg trunk cable and connector block of the mrx could be susceptible to accelerated wear, which could result in an interrupted ecg signal. interruption of the ecg signal can cause: - loss of demand mode pacing- inability to perform synchronized cardioversion with paddles- disruption of leads ecg monitoring, which could delay appropriate treatmentdefibrillation, fixed mode pacing, ecg monitoring via pads/paddles and other monitoring functions are not impacted by this issue.
  • 조치
    Philips is initiating a hardware upgrade to the affected devices. Users can continue to use the MRx prior to receiving the hardware upgrade while remaining aware of the issues identified above. If the problem occurs refer to the HeartStart MRx Instructions For Use for troubleshooting assistance. Additional workaround instructions are provided in the customer letter.

Device

Philips HeartStart MRx Monitor/Defibrillator
  • 모델명 / 제조번호(시리얼번호)
    Philips HeartStart MRx Monitor/Defibrillator Model numbers: M3535A, M3536A, M3536J, M3536M, M3536M5, and M3536MCUnits Affected: Serial numbers within the range US00100100 - US00550668ARTG Number: 95661
  • 의료기기 분류등급
    Cardiovascular Devices
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

Philips Electronics Australia Ltd
  • 제조사 모회사 (2017)
    Philips
  • Source
    DHTGA