Events

Philips Expression Information Portal - IP5 (Multiparameter patient 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-2013-RN-01052-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2013-10-11
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01052-1
  • 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
    If an ip5 is in use or powered on for an extended period of time (exceeding 24 hours), the ip5 may lost all audio function. "all audio" includes touch screen and qrs/spo2 modulation tones and audible alarms. all other functionality of the ip5 is unaffected (waveforms, numeric values, visual alarm indications).
  • 조치
    A Philips representative will contact the affected customer to arrange for a software update to correct the problem. End users are requested to power cycle the IP5 once every 24 hours and to be aware not to rely solely on audible alarms for alerting of potentially critical patient events.

Device

Philips Expression Information Portal - IP5 (Multiparameter patient monitor)
  • 모델명 / 제조번호(시리얼번호)
    Philips Expression Information Portal - IP5 (Multiparameter patient monitor)Product Number: 865471Serial Numbers: US23200375, US23200376, US23200377ARTG Number: 189095
  • 의료기기 분류등급
    Cardiovascular Devices
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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