Events

Philips HeartStart XL+ Defibrillator/Monitor 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-00477-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2014-04-28
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00477-1
  • 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
    A software communication failure on the heartstart xl+ that occurs during an automated ready-for-use test or at turn-on may lock the user out of clinical mode, which may delay therapy. the communication error can trigger a false failure condition - error code 1:34 "equipment disable: therapy". if the user is locked out of clinical mode, a delay in therapy may occur, which could pose a risk for patients.
  • 조치
    Philips is providing a software update to correct the issue. End users are advised while awaiting the software upgrade for the affected device users may continue to use the HeartStart XL+ unless the device exhibits a Red X, presents an audio chirp and displays the user message: “Equipment Disabled: Therapy”. This is an indicator that the device self-test has detected the problem and is not ready for use. In the case the problem cannot be resolved by running Op-Check, users should identify a readily available backup defibrillator to use in the event the affected HeartStart XL+ exhibits the communication failure. This action has been closed-out on 01/02/2016.

Device

Philips HeartStart XL+ Defibrillator/Monitor
  • 모델명 / 제조번호(시리얼번호)
    Philips HeartStart XL+ Defibrillator/MonitorModel Number: 861290.Units upgraded to B.00.01 software, or manufactured by Philips between December, 2013 and February, 2014Multiple serial numbers affectedARTG Number: 95661
  • 의료기기 분류등급
    Cardiovascular Devices
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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