Events

Philips HeartStart MRx Monitor/Defibrillators 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-2015-RN-00149-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2015-02-20
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00149-1
  • 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 mrx could reboot once in any operating mode if the following sequence occurs:1. in service mode, the status log is cleared 2. prior to exiting service mode, the mrx generates an entry in the status log.3. service mode is exited.The mrx will restart within 8 seconds. if a reboot occurs during clinical use, current device settings and patient record are retained.
  • 조치
    A software upgrade will be provided to correct the issue. Philips is advising end users that the MRx can continue to be used prior to receiving the software update. End users are advised that if the MRx reboots during clinical use, continue to treat the patient according to your organization’s protocol, reinitiating therapy if necessary.

Device

Philips HeartStart MRx Monitor/Defibrillators
  • 모델명 / 제조번호(시리얼번호)
    Philips HeartStart MRx Monitor/DefibrillatorsUnits Affected:Model - Serial numbersM3535A: US00100100 to US00578696M3536A: US00100902 to US00576650M3536J: US00209838 to US00332675M3536M: US00500002 to US00553553M3536MC: US00500001 to US00500087M3536M2: US00554176, US00554177, US00554178M3536M5: US00500001 to US00562935M3536M6: US00554358 to US00576619ARTG number: 95661
  • 의료기기 분류등급
    Cardiovascular Devices
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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