Events

qube Compact Monitor (Transportable mutiparameter 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-2014-RN-00712-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-07-04
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00712-1
  • 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 issue with the qube compact monitors that are “docking station ready” that have had a port cover plate removed allowing the monitor to be used with the optional qube docking station. if a docking station ready qube monitor is powered up undocked, connected to the network via an ethernet hardwire connection, and then disconnected from the ethernet hardwire connection and inserted into a qube docking station, a switch condition will cause the monitor to lose the network connection. all bedside alarms will continue to function normally.
  • 조치
    If the users dock the monitor and lose network connection, power down the monitor and turn it back on to restore normal function. To prevent this error from happening, users are advised to avoid transitioning from hardwire ethernet connection to a docking station without powering down the device. Medtel Pty Ltd will contact affected sites to schedule a convenient time to correct the sites affected qube monitors.

Device

qube Compact Monitor (Transportable mutiparameter patient monitor)
  • 모델명 / 제조번호(시리얼번호)
    qube Compact Monitor (Transportable mutiparameter patient monitor)Catalogue Number: 91390Serial Numbers: 1390-000290, 1390-000291, 1390-000337, 1390-000338, 1390-000339, 1390-000340, 1390-000607, 1390-000608, 1390-000609, 1390-000610, 1390-000689, 1390-000690, 1390-000691,1390-000692, 1390-000693, 1390-000695, 1390-100047, 1390-100048, 1390-101245, 1390-102559, 1390-102560, 1390-102561, 1390-102562, 1390-102563ARTG Number: 108755
  • Manufacturer
    Medtel Pty Ltd

Manufacturer

Medtel Pty Ltd
  • Source
    DHTGA