Events

CARDIOHELP Perfusion System, Software versions prior to 3.4.6.0 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Maquet 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-2015-RN-00117-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2015-02-12
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00117-1
  • 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
    Maquet cardiopulmonary has received several complaints from the field reporting that after startup with either ac or dc power, the cardiohelp system generated the pop-up window "battery x needs service" or "both batteries need service" (x refers to the number of built-in battery, e.G.Battery 1). the alarm messages did not occur during device operation (including the switch from ac to dc power and vice versa) .Maquet cardiopulmonary's internal investigations have identified that there is a likely occurrence of the above mentioned error messages due to software bugs in the communication between the controller module and operating system . however, it is not possible for the user to distinguish the genuine alarm messages caused by batteries from the incorrect alarm messages caused by the software bugs. maquet cardiopulmonary received no reports of any adverse patient outcomes as a result of this error message.
  • 조치
    The new software version (version 3.4.6.0) corrects software bugs that resulted in the generation of incorrect "Battery Needs Service" error messages. This software revision and the method for upgrading affected systems will be provided via the normal Service Letter process. This action has been closed-out on 11/08/2016.

Device

CARDIOHELP Perfusion System, Software versions prior to 3.4.6.0
  • 모델명 / 제조번호(시리얼번호)
    CARDIOHELP Perfusion System, Software versions prior to 3.4.6.0 ARTG Number: 179104
  • Manufacturer
    Maquet Australia Pty Ltd

Manufacturer

Maquet Australia Pty Ltd