Events

CARESCAPE Central Station (CSCS) software version 2.0.2 All-in-one 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-2018-RN-00046-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2018-01-12
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00046-1
  • 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
    Ge healthcare has become aware of an issue with the carescape central station (cscs) software version 2.0.2 units. after boot-up or system start up, cscs v2.0.2 units may display unexpected no comm notifications in the patient multi-viewer or single viewer window when the cscs is connected to both the mission critical (mc) and the information exchange (ix) networks. if a no comm notification is displayed, all patient waveforms, parameter data and alarms are lost at the cscs and patients admitted to telemetry transmitters are unmonitored unless monitored via other central stations, bedside monitors or direct clinical observation. there have been no injuries reported as a result of this issue.
  • 조치
    GE Healthcare is advising customers who are experiencing the NO COMM safety issue to follow instructions outlined on the customer letter to restore communication between the CSCS and patient monitoring devices in the interim. GE will arrange for a software correction to resolve this issue.

Device

CARESCAPE Central Station (CSCS) software version 2.0.2 All-in-one
  • 모델명 / 제조번호(시리얼번호)
    CARESCAPE Central Station (CSCS) software version 2.0.2 All-in-one GTIN 00840682109666; Desktop GTIN 00840682109604ARTG Number: 132673 (GE Medical Systems Australia Pty Ltd - Patient monitor, central unit)
  • 의료기기 분류등급
    Cardiovascular Devices
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd