Events

Prism Medical P300 and C300 Lifts 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Rehab Assist 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-00967-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-09-30
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00967-1
  • 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
    Prism has been made aware of 17 incidents involving 300 series lifts in which the drive gear shaft has broken, eliminating the lifts ability to raise or lower a patient. of these 17 incidents we have discovered 3 in which the free fall protection system did not engage properly. if both of these incidents occur atthe same time there is a risk for the person being supported by the lift to drop unexpectedly. the patients involved in the 3 incidents were not seriously injured and did not require medical attention.
  • 조치
    Rehab Assist will replacing the affected units with a new unit. For further information please see https://www.tga.gov.au/alert/prism-medical-p300-and-c300-ceiling-hoist. This action has been closed-out on 18/08/2016.

Device

Prism Medical P300 and C300 Lifts
  • 모델명 / 제조번호(시리얼번호)
    Prism Medical P300 and C300 LiftsLifter P300Models: 303050; 303051Serial: P303470 – 479, P304158/164/171/172, P304536 – 539, P304866/867, P305116/118, P305125 – 127, P305130/134/135Lifter C300Models: 330050; 330053Serial: C303221/224/225, CQ303107 – 116Lifts manufactured prior to 8 June 2015ARTG Number: 169639
  • Manufacturer
    Rehab Assist Pty Ltd

Manufacturer

Rehab Assist Pty Ltd