Events

Single Limb Circuit for Pneupac Ventilators, with PEEP Valve 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Smiths Medical Australasia 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-00047-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2015-01-19
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00047-1
  • 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
    Certain single limb circuits were labelled as “mr conditional” but contained peep valves that should have been labelled as “mr unsafe”.If the affected products are used in an mr environment, there is a potential for the peep valve to become dislodged during the mri procedure. the effect of a reduction of peep pressure could be a reduction in oxygen saturation of the blood which would be detectable by clinical observation of signs and symptoms and through oximetry. also there is the potential for the affected products to create artifacts in the mri scan; however, these artifacts would be highly detectable by the clinician reading the mri.
  • 조치
    Facilities that use the Single Limb Circuit in the MRI suite are requested to quarantine the affected devices. A Smiths Medical representative will arrange for the exchange of unused affected product. This action has been closed-out on 08/08/2016.

Device

Single Limb Circuit for Pneupac Ventilators, with PEEP Valve
  • 모델명 / 제조번호(시리얼번호)
    Single Limb Circuit for Pneupac Ventilators, with PEEP ValveOrder code:100/905/301 Batch numbers: 121105, 130128, 130225, 130408, 130624, 131209, 140217, 140407, 140428 & 140616 Order code:100/905/302Batch numbers: 120229, 120326, 120402, 120507, 120716, 120820, 130318, 130520, 130819, 131007, 131125, 131216, 140526, 140707 & 140714 ARTG number: 109570
  • Manufacturer
    Smiths Medical Australasia Pty Ltd

Manufacturer

Smiths Medical Australasia Pty Ltd