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-00209-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2014-02-25
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00209-1
  • 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
    An internal component on the heartstart xl power board may malfunction potentially affecting the ability to deliver therapy. specifically, the xl may be unable to charge and deliver a shock. in addition, when used for external pacing, the malfunction may result in a loss of capture.
  • 조치
    Philips will be installing replacement power boards to correct the problem. A Philips representative will be in contact with customers to make arrangements for the correction. While awaiting the replacement power board for the device, users may continue to use the HeartStart XL. Identify a readily available backup defibrillator to use in the event the affected HeartStart XL fails to deliver therapy. This action has been closed-out on 11/02/2016.

Device

Philips HeartStart XL, Defibrillator/Monitor
  • 모델명 / 제조번호(시리얼번호)
    Philips HeartStart XL, Defibrillator/MonitorModel Number: M4735AUnits Affected: Units manufactured by Philips between May, 2013 and November, 2013 Serial numbers within the range: US00101665 to US00608704
  • 의료기기 분류등급
    Cardiovascular Devices
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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