Events

Pivot, Pivot Hygiene, Pivot Hammock and Tony Pringle clip style sling with the keyhole clip fastening 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Active Medical Supplies 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-2017-RN-00522-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-06-26
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00522-1
  • 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
    The manufacturer nortec medical have advised that the keyhole clips on pivot, pivot hygiene, pivot hammock and tony pringle clip style sling may break. there have been four recorded cases of failure of the keyhole clip that attaches a sling to a pivot framed hoist. these keyhole clips are the black plastic component which is attached to the sling by means of a webbing strap threaded through a slot. the affected clips have all broken at the slot.If the clip on the sling were to fail under load (whilst a patient is being transferred), the patient will fall from the hoist.
  • 조치
    Active Medical requests that all recalled sling/s must be removed from service and disposed of. Users are requested to return a completed Urgent Medical Device Recall Notification form (provided with the Customer letter) and return it to Active Medical Supplies at recalls@activemedicalsupplies.com.au or fax to (07) 3899 8825 or post to Active Medical Supplies – Quality Assurance PO BOX 3392 TINGALPA QLD 4173. Replacement slings will be made available to affected customers.

Device

Pivot, Pivot Hygiene, Pivot Hammock and Tony Pringle clip style sling with the keyhole clip faste...
  • 모델명 / 제조번호(시리얼번호)
    Pivot, Pivot Hygiene, Pivot Hammock and Tony Pringle clip style sling with the keyhole clip fasteningARTG Number: 146792
  • Manufacturer
    Active Medical Supplies Pty Ltd

Manufacturer

Active Medical Supplies Pty Ltd