Events

Infinity MCable Mainstream Sensor, Revision 16 only (used with Acute Care System (IACS) Monitoring Solution; and the Infinity M540 Stand-Alone Patient Monitor) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Draeger 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-2018-RN-00265-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2018-03-26
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00265-1
  • 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
    Drager has determined that when the infinity m540 patient monitor with software versions vg4.1 and below is used in combination with the infinity mcable mainstream c02 (m11.1) revision 16 sensor, the infinity m540 patient monitor will reboot if the sensor enters a reduced accuracy mode. should the infinity m540 patient monitor reboot 3 times within a 10 minute period or less, the infinity m540 patient monitor will go into a fail-state, resulting in a resetting to factory defaults, losing patient settings and stored patient data.This issue only occurs with infinity cable revision 16. there have been no injuries reported as a result of this issue.
  • 조치
    Drager is advising users to discontinue use the Infinity CO2 sensor, revision 16. Drager will be replacing all revision 16 cables with an earlier revision as an interim correction. A software update will be implemented as a long term correction.

Device

Infinity MCable Mainstream Sensor, Revision 16 only (used with Acute Care System (IACS) Monitorin...
  • 모델명 / 제조번호(시리얼번호)
    Infinity MCable Mainstream Sensor, Revision 16 only (used with Acute Care System (IACS) Monitoring Solution; and the Infinity M540 Stand-Alone Patient Monitor) Part Number: 6871950Serial Numbers: ASKJ-0016, ASKH-0285, ASKH-0287, ASKK-0180, ASKK-0323, ASKK-0381ARTG Number: 140750Draeger Australia - Carbon dioxide sensor cable
  • Manufacturer
    Draeger Australia Pty Ltd

Manufacturer

Draeger Australia Pty Ltd