Entroy Pool Lifter 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Arjo Australia 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-2018-RN-00230-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2018-03-26
  • 사례 국가
  • 사례 출처
    DHTGA
  • 사례 출처 URL
  • 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
    Arjo have identified a potential for the chair or stretcher detachment from entroy pool lifter. it is identified that this issue is caused by a potential misalignment that might be unnoticed by the caregiver so the seat/stretcher does not get fully paired with the pin. instead, once the lift reaches certain height, the seat/stretcher falls off the lift. there are one or more possible reasons that can lead to such a situation to occur: - maintenance checks not performed properly,- users do not recognize the poor connection,- pool lift owners does not recognise that the product needs maintenance, - wear on the docking connection causes the pin to hit the edge of the pairing cylinder instead of entering it.
  • 조치
    Arjo are advising users that they will arrange for an on-site service technician visit to install a Quick Reference Guide, which is an illustration-based instruction, which users may refer to ensure a patient transfer is conducted as indicated in the IFU.

Device

  • 모델명 / 제조번호(시리얼번호)
    Entroy Pool LifterModel Number: GAB1000-x01Affected Serial Numbers 810000957 up to T3387 ARTG: 230595Arjo Australia - Lift, patient transfer, stationary
  • Manufacturer

Manufacturer

  • Source
    DHTGA