Philips IntelliVue Information Center iX (PIIC iX) software release A.01.XX (Central patient monitoring station) 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-00259-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2013-03-21
  • 사례 국가
  • 사례 출처
    DHTGA
  • 사례 출처 URL
  • 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
    Philips has received a customer report that the piic ix (release a.01.Xx) central stations that are connected to a database server (dbs) may not be able to complete a restart/reboot resulting in the loss of central monitoring. this defect occurs when the following two criteria are met:1. the workflow for reviewing stored patient data on the piic ix involves the modification of the default trend scales in the retrospective review applications and these trend scales are customised for hundreds of different patients (within a period of seven days or less); and2. a planned/unplanned event resulting in the restart/reboot of the piic ix central stations (e.G. deliberate reboot, network connection to the dbs is lost and piic central stations go into local mode, power failure, etc.).
  • 조치
    End users are provided with instructions to prevent the defect from occurring. A Philips Healthcare representative will contact customers with affected devices to arrange for the installation of updated PIIC iX software, resolving this issue on all affected units.

Device

  • 모델명 / 제조번호(시리얼번호)
    Philips IntelliVue Information Center iX (PIIC iX) software release A.01.XX (Central patient monitoring station)ARTG Number: 94237
  • Manufacturer

Manufacturer

  • 제조사 모회사 (2017)
  • Source
    DHTGA