Events

Corpuls3 CO2 Disposable Naso-oral Adaptor Capone 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-2017-RN-00535-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-05-01
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00535-1
  • 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 have been two local reports of the mouth piece part of the device being dislodged into the throats of patients. the mouth piece is manufactured to be manually removed if clinically necessary. the results of an investigation revealed that it occurred due to a high level of patient agitation. there is a potential risk of asphyxiation if this problem occurs.
  • 조치
    Device Technologies is updating the IFU (Instructions for Use) to state that it should only be used on patients who can tolerate the adapter and that the oral breath collector may come loose under extreme conditions and could be aspirated. Users are also requested to retain a copy of their recall letter with the IFU of the affected device.

Device

Corpuls3 CO2 Disposable Naso-oral Adaptor Capone
  • 모델명 / 제조번호(시리얼번호)
    Corpuls3 CO2 Disposable Naso-oral Adaptor CaponeProduct Code: CP-4234.21All Lot NumbersARTG Number: 281369 and 192745
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd