Events

Vapotherm Disposable Patient Circuit System (Delivers high flow humidified gases via a nasal cannula or other patient interface) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Surgical Specialties 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-2014-RN-00916-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-08-22
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00916-1
  • 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
    Vapotherm inc. has received a small number of complaints involving a defect in the disposable patient circuit delivery tube. the defect allows water to leak into the centre lumen of the delivery tube, the gas line to the patient. the fault condition is easily detectable and typically occurs while the device is coming up to the set temperature and is easily visible when following the precision flow instructions for use, which requires that the cannula be connected to the patient only after the set temperature is reached.
  • 조치
    Customers are asked to check their stock immediately to determine if they have any affected product. Customers are advised to return the affected stock to Surgical Specialties Pty Ltd. This action has been closed-out on 10/05/2017.

Device

Vapotherm Disposable Patient Circuit System (Delivers high flow humidified gases via a nasal cann...
  • 모델명 / 제조번호(시리얼번호)
    Vapotherm Disposable Patient Circuit System (Delivers high flow humidified gases via a nasal cannula or other patient interface)Part Numbers: PF-DPC-High, PF-DPC-Low Lot Numbers: HF1402035, HF1404043, LF1402030, LF1405023ARTG Number: 147794
  • Manufacturer
    Surgical Specialties Pty Ltd

Manufacturer

Surgical Specialties Pty Ltd