Events

AIRVO 2 / myAIRVO 2 HumidifierAIRVO 2 Humidifier 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Fisher & Paykel Healthcare 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-2016-RN-00729-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2016-06-08
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00729-1
  • 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
    Fisher & paykel has updated the airvo 2 / myairvo 2 user instructions to include a check that the speaker is audible prior to each patient use in order to ensure the speaker is functioning.
  • 조치
    Fisher & Paykel are advising users that the AIRVO 2 / myAIRVO 2 User Instructions have been updated to include a warning for the user to check speaker functionality before each patient use, using the steps in the User Instructions. First turn the unit on and then remove the heated breathing tube. The user should see the “check tube” visual signal and hear the speaker signal. If either signal is absent, users are advised not to use the unit and contact their Fisher & Paykel representative to arrange for a replacement device.

Device

AIRVO 2 / myAIRVO 2 HumidifierAIRVO 2 Humidifier
  • 모델명 / 제조번호(시리얼번호)
    AIRVO 2 / myAIRVO 2 HumidifierAIRVO 2 HumidifierModel Number: PT101XXmyAIRVO 2 HumidifierModel Number: PT100XXAffected Serial Numbers: 120521YYYYYY – 160605YYYYYYARTG Number: 177298
  • Manufacturer
    Fisher & Paykel Healthcare Pty Ltd

Manufacturer

Fisher & Paykel Healthcare Pty Ltd