Events

Patient Data Module (PDM) used with B850, B650, B450, Solar 8000i and MacLab / ComboLab (multifunction patient monitor module) 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-01234-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2013-11-26
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01234-1
  • 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 spring inside the mounting latch can become dislodged causing the pdm not to latch properly resulting in an unexpected loss of patient monitoring function. this may also result in the pdm falling onto a patient or caregiver. warning messages are displayed indicating patient parameters which have been disconnected and also, a three short burst alarm is issued and repeated if acknowledged.
  • 조치
    GE Healthcare is advising users to refrain from mounting the monitor above a patient or caregiver and refrain from mounting the monitor at a downward facing angle. GE Healthcare will be installing a new latch on all units once available. This action has been closed-out on 10/02/2016.

Device

Patient Data Module (PDM) used with B850, B650, B450, Solar 8000i and MacLab / ComboLab (multifun...
  • 모델명 / 제조번호(시리얼번호)
    Patient Data Module (PDM) used with B850, B650, B450, Solar 8000i and MacLab / ComboLab (multifunction patient monitor module)Product Codes: SA3, SG5All monitors produced from April 2007 to December 2012.Serial Numbers: SA030713XXXXXX to SA31252XXXXXX and SG050713XXXXXX to SG51252XXXXXXARTG Number: 118982
  • 의료기기 분류등급
    Cardiovascular Devices
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd