Events

Ultraview SL Command Module(Patient monitoring system)Modules shipped or repaired after 8 March 2015 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-2015-RN-00445-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-05-28
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00445-1
  • 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
    Due to a software defect the ultraview sl command module can in advertently reset. the reset sequence takes approximately 10 seconds and during this period monitoring of all parameters will be suspended. upon completion of the reset sequence, all alarm limits will be reset to their site-defined default values. critical alarms for ventricular fibrillation and asystole are always enabled after the reset. if invasive pressure is being monitored, labels will be reset to default values and the zero calibration will be lost. if non-invasive pressure is being monitored, the automatic measurement mode will be disabled.A separate failure mode can also occur where the spo2 menu keys become unresponsive and prevent user changes to spo2 operation and alarm settings. in this state, all alarm limits, alarm functions and parameter monitoring continue unaffected and all alarm limits other than spo2 can still be adjusted.
  • 조치
    Medtel Pty Ltd will contact users to schedule a convenient time to correct all of the affected Ultraview SL Command Modules at no cost. This action has been closed-out on 11/08/2016.

Device

Ultraview SL Command Module(Patient monitoring system)Modules shipped or repaired after 8 March 2015
  • 모델명 / 제조번호(시리얼번호)
    Ultraview SL Command Module(Patient monitoring system)Modules shipped or repaired after 8 March 2015Catalogue number: 91496ARTG number: 109585
  • Manufacturer
    Medtel Pty Ltd

Manufacturer

Medtel Pty Ltd
  • Source
    DHTGA