Events

Spacelabs Healthcare Qube Compact Monitor (Multi parameter transportable patient monitor) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Medtel 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-2012-RN-01136-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2012-11-08
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01136-1
  • 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
    There is a potential failure of the qube compact monitor where the input power can fail even though the power source at the wall has not been interrupted. the monitor automatically goes into battery mode and functions normally, including the low battery alerts, until the batteries become depleted and the monitor turns off. in addition, there is the potential for the qube compact monitor to fail to turn on.
  • 조치
    As an interim measure, Medtel is providing work around instructions to reduce the probability of occurrence. New hardware will be installed to permanently correct the issue as soon as possible.

Device

Spacelabs Healthcare Qube Compact Monitor (Multi parameter transportable patient monitor)
  • 모델명 / 제조번호(시리얼번호)
    Spacelabs Healthcare Qube Compact Monitor (Multi parameter transportable patient monitor)Serial Numbers:1390 - 000340, 1390 - 000339, 1390 - 000338 & 1390 - 000337ARTG Number: 108755
  • Manufacturer
    Medtel Pty Ltd

Manufacturer

Medtel Pty Ltd
  • Source
    DHTGA