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-2017-RN-00490-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2017-04-19
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00490-1
  • 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 an investigation of the reported customer complaints, the manufacturer has identified that there is a potential for some circuits of the affected batches to operate incorrectly. the 10mm female connector was slightly oversized during its manufacturing and therefore the device could become loose from the fisher & paykel neopuff’s 10mm male connector under certain conditions and would therefore not deliver the required pressure to the patient.
  • 조치
    Affected Lots are being recalled from Hospitals. Users are requested to note this is an expanded recall from December 2016 where this issue was first identified and Batch Number: TB2000-0141 was recalled.

Device

TB2000 Disposable t-piece infant resuscitation circuit with adjustable PEEP
  • 모델명 / 제조번호(시리얼번호)
    TB2000 Disposable t-piece infant resuscitation circuit with adjustable PEEPThis Recall:- Batch / Lot Number: TB2000-0146, TB2000-0149 and TB2000-0151Previous Recall from December 2016:- Batch / Lot Number: TB2000-0141ARTG Number: 188097
  • Manufacturer
    Swirl Technologies Pty Ltd T/A Parker Healthcare

Manufacturer

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