Events

B20, B30, B40 Patient Monitors (used for ECG monitoring) 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-2013-RN-01027-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2013-10-02
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01027-1
  • 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
    The b20, b30 and b40 patient monitors set the ecg filter setting incorrectly if the monitor starts with impedance respiration set in the on position. instead of the user selected filter, an additional 0.5 hz high pass filter is used. the additional 0.5 hz high pass filter causes changes to the ecg waveform morphology and incorrect display of st values. the st-elevation measurement can be under estimated in this situation and treatment of the patient can be delayed.Please note that there is no issue when the monitor starts with impedance respiration set in the off position.
  • 조치
    GE Healthcare is providing users with work around instructions to follow until a software correction is available.

Device

B20, B30, B40 Patient Monitors (used for ECG monitoring)
  • 모델명 / 제조번호(시리얼번호)
    B20, B30, B40 Patient Monitors (used for ECG monitoring)Serial Numbers: B20 - SGF11030001WA to SGF13176741WA (software version 1)B30 - SF309380033WA to SF313177120WA (software version 2)B40 - SG211210001WA to SG213172146WA (software version 1)B40 - SJF13010005WA to SJF13180144WA (software version 2)ARTG Number: 92726
  • 의료기기 분류등급
    Cardiovascular Devices
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd