Events

Acutronic Fabian HFO (High Frequency Oscillation) Ventilators , software versions below GUI 3.0.2.7PN 7200 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Medical Technologies 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-00095-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2015-02-06
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00095-1
  • 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
    Medical technologies is informing end users of an extremely rare software problem. the problem is withinthe embedded software of the fabian hfo. fabian hfo devices may as a symptom exhibit a halting user interface (touchscreen and/or hard keys). if this happens, it will no longer be possible to adjust the parameter settings. the current ventilation parameters are maintained and there is no interruption to ventilation.
  • 조치
    In the event of this problem occurring, it is recommended to transfer the patient to an alternative ventilator. The fabian HFO can continue to be used ONLY in the event where no other ventilator is available in the facility as the single fault condition alarms in the event of a halting user interface, alerting the operator. All fabian HFO ventilators will be updated with software GUI 3.0.2.7 made available by Acutronic. This will prevent the described problem. In addition, Acutronic software has a new watchdog implementation that monitors the state of the serial communication. A failsafe mechanism triggered by watchdog will prevent further similar occurrences from happening. This action has been closed-out on 15/07/2016.

Device

Acutronic Fabian HFO (High Frequency Oscillation) Ventilators , software versions below GUI 3.0.2...
  • 모델명 / 제조번호(시리얼번호)
    Acutronic Fabian HFO (High Frequency Oscillation) Ventilators , software versions below GUI 3.0.2.7PN 7200All serial numbers suppliedARTG Number: 185053
  • Manufacturer
    Medical Technologies Pty Ltd

Manufacturer

Medical Technologies Pty Ltd