Events

CareFusion - AVEA Ventilator 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Device Technologies 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-00433-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2015-05-21
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00433-1
  • 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
    When the avea ventilator develops a malfunction of the pressure transducer in the ventilator that measures the inspiratory or expiratory pressure of the circuit, a false alarm is initiated indicating an extended high ppeak or circuit occlusion depending on the specific failure mode within the pressure transducer. most reports of ext high ppeak or circuit occlusion alarms have been detected prior to use of the ventilator on a patient. if a malfunction occurs, a delay of initiation of ventilation may result. under these circumstances, the ventilator by design will alarm and cease ventilation. the safety valve will open allowing patients that can spontaneously breathe to do so. the reported rate of occurrence is very low with no reports of patient injury received to-date.
  • 조치
    Customers are advised that they will be contacted by a Device Technologies representative to arrange for onsite remediation of the affected devices, in the interim if any AVEA ventilator unit exhibits a sustained Ext High Ppeak or Circuit Occlusion alarm followed by the opening of the Safety Valve, that cannot be cleared by powering the ventilator off and back on again, immediately remove the ventilator from service, provide alternate ventilation and contact Device Technologies Technical Support.

Device

CareFusion - AVEA Ventilator

Manufacturer

Device Technologies Australia Pty Ltd