Events

BVM (Bag-Valve-Mask) Manual Resuscitation Systems 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Medical Developments International Limited 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-00838-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2017-07-05
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00838-1
  • 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
    Medical developments international has identified the possibility that the valve of the bvm manual resuscitation system may become stuck during storage. this could result in the intended tidal volume not being delivered through the valve, which may cause a delay in treatment.The instructions for use (ifu) provided with these products include the requirement to ensure the bag, valve and oxygen delivery is functioning correctly prior to use.
  • 조치
    Medical Developments International is requesting users inspect their stocks and quarantine all units from the affected batch numbers, then complete the supplied Reply Form and email or fax it back so that we may arrange collection and issue credit. Please complete the Reply Form even if you have no stock which is subject to recall, as we require this information to reconcile the process.

Device

BVM (Bag-Valve-Mask) Manual Resuscitation Systems
  • 모델명 / 제조번호(시리얼번호)
    BVM (Bag-Valve-Mask) Manual Resuscitation SystemsCatalogue Number: RS-7595-BVMDAWBatch Numbers: up to 1170328006Catalogue Number: RS-7595-BVMDABatch Numbers: up to 1160629050Catalogue Numbers: RS-7595-BVMDC, RS-7595-BVMDC3Batch Numbers: up to 1160728029Catalogue Number: RS-7595-BVMDC3Batch Numbers: up to 11600922002ARTG Number: 147543
  • Manufacturer
    Medical Developments International Limited

Manufacturer

Medical Developments International Limited