Events

TB2000 Disposable t-piece infant resuscitation circuit with adjustable PEEP 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Swirl Technologies Pty Ltd T/A Parker Healthcare 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-01577-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-12-06
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01577-1
  • 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
    During investigation of the reported complaints from the field, the manufacturer has identified that there is a potential for some circuits of the affected batch to operate incorrectly. the 10 mmf connector of the circuits was slightly oversized during its manufacturing and therefore the device could become loose from the fisher & paykel neopuff’s 10 mmm connector under certain pressure and would not deliver the required pressure to the patient.
  • 조치
    All remaining TB2000 circuits from the affected Batch TB2000-0141 will be replaced with unaffected batches without any additional costs to the customer. Customers are advised to isolate the affected units and contact Parker Healthcare Customer Service Department or their sales representative to organise the return of the recalled stock and to get replacement stock. This action has been closed-out on 26/05/2017.

Device

TB2000 Disposable t-piece infant resuscitation circuit with adjustable PEEP

Manufacturer

Swirl Technologies Pty Ltd T/A Parker Healthcare
  • Source
    DHTGA