HeartSineTechnologies Pad-Pak/ Pedi-Pak (contains non-rechargeable battery and defibrillation electrodes for use with the HeartSine Samaritan PAD 350P and 500P Defibrillators) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Aero 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-2014-RN-00655-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2014-06-18
  • 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
    During testing at heartsine technologies ltd, an issue has been detected with the seal on the foil pouch which contains the electrodes within the pad-pak and pedi-pak. on a small number, the final seal on the defibrillation electrode pouch was found to be difficult to open. the investigation identified that the supplier of the electrodes to heartsine technologies ltd had made a change to the manufacturing process which meant that an excessive amount of hot melt glue was applied to the final seal of the pouches.
  • 조치
    Aero Healthcare is advising that all the affected units are within the control of the distributors. The distributors are advised that the affected units should be placed in quarantine to await collection by Aero Healthcare.

Device

  • 모델명 / 제조번호(시리얼번호)
    HeartSineTechnologies Pad-Pak/ Pedi-Pak (contains non-rechargeable battery and defibrillation electrodes for use with the HeartSine Samaritan PAD 350P and 500P Defibrillators)Lot Numbers: A1754, A1795, A1792, A1789, A1802 ARTG Numbers: 161839 (Adult Pad-Pak) and 161841 (Paediatric Pedi-Pak)
  • Manufacturer

Manufacturer