CareScape Patient Data Module (PDM) with software v2.6(used with CareScape Monitors B850, B650 and B450 with v2.0.7 or earlier software) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 GE Healthcare Australia Pty 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-2017-RN-00873-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-07-20
  • 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
    Ge healthcare observed during a pre-installation checkout procedure that an impedance respiration apnea alarm could not be produced with pdm v2.6 and carescape b850 v 2.0.7 host monitor software. the pdm v2.6 has been limited to a small number of customer sites. the issue was identified in the biomed shop during check out. to date, no actual reported patient incidents of a missed apnea alarm with pdm v.2.6 have been reported.
  • 조치
    GE Healthcare will correct all affected products at no cost to users. A GE Healthcare representative will contact each affected site to arrange for the correction to take place.

Device

  • 모델명 / 제조번호(시리얼번호)
    CareScape Patient Data Module (PDM) with software v2.6(used with CareScape Monitors B850, B650 and B450 with v2.0.7 or earlier software)ARTG Number 118982
  • Manufacturer

Manufacturer