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-2014-RN-01276-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2014-12-08
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01276-1
  • 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 contain incorrect internal software settings, causing the following two issues:1. the device will perform the weekly automated tests hourly, which could cause the therapy capacitors to degrade sooner than intended.2. while connected to ac or dc power and with no battery installed or the battery installed has a charge level of less than 10%, the ready for use (rfu) indicator will not provide the expected low battery indication (flashing red x with audible chirp). instead, the rfu will show a flashing black hourglass, indicating that sufficient battery power is available for device operation. there is a potential for a delay in therapy due to insufficient battery power.
  • 조치
    Philips is initiating a correction that will consist of replacement of the therapy capacitor and reset of internal software settings. Prior to receiving correction, customers can continue to use the affected MRx provided that they follow workaround steps identified in the customer letter. These steps will prevent further accelerated degradation of the therapy capacitor, and will eliminate the above described behaviour for no/low battery conditions.

Device

Philips HeartStart MRx Monitor/Defibrillators

Manufacturer

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