Events

A3/A5 Anesthesia Delivery System 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Ulco Engineering 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-2012-RN-01161-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2012-12-21
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01161-1
  • 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
    There is the possibility of a system leak resulting from improper seating of the co2 absorbent canister gasket. should a system leak occur during use, fresh gas flow may be increased to compensate for any pressure loss resulting from the leak while the absorbent canister is unlocked, and locked again to reseat the gasket. if the co2 absorbent gasket is improperly seated, however a potential leak will likely present itself during the automatic circuit leak and compliance test performed at startup and the manual leak test recommended to be performed before each case, at which time the absorbent canister can be unlocked and locked again to reseat the gasket.This recall action was not notified to the tga before it was initiated by ulco medical.
  • 조치
    Ulco Medical is providing work around instructions and will be replacing the canister gasket to permanently correct the issue.

Device

A3/A5 Anesthesia Delivery System
  • 모델명 / 제조번호(시리얼번호)
    A3/A5 Anesthesia Delivery SystemARTG:158607
  • Manufacturer
    Ulco Engineering Pty Ltd

Manufacturer

Ulco Engineering Pty Ltd
  • Source
    DHTGA