Events

CARDIOSAVE Hybrid intra-aortic balloon pump (IABP) and CARDIOSAVE Rescue IABP 를 위한 안전성 경고 / 현장 안전성 서한

Medicines and Healthcare products Regulatory Agency에 따르면, 해당 안전성 경고 / 현장 안전성 서한 는 United Kingdom 에서 Maquet 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

현장 안전성 서한은 의료기기 제조사 또는 제조사 대리인이 시중에 유통되고 있는 자사 의료기기 제품에 대하여 취할 수 있는 조치를 알리는 소통방식입니다. 주요 대상층은 보건의료업계 종사자와 의료기기 사용자들입니다. 여기에는 회수(recall) 조치와 경고도 포함될 수 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert / Field Safety Notice
  • 날짜
    2017-03-07
  • 사례 출판 날짜
    2017-03-07
  • 사례 국가
    United Kingdom
  • 사례 출처
    MHRA
  • 사례 출처 URL
    https://www.gov.uk//drug-device-alerts/cardiosave-hybrid-intra-aortic-balloon-pump-iabp-and-cardiosave-rescue-iabp-damaged-lithium-ion-batteries-may-give-off-smoke-a-bad-smell-or-produce-sparks
  • 비고 / 경고
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • 데이터 추가 비고
  • 원인
    Manufactured by maquet – until storage cases are available, avoid carrying spare batteries when transporting the iabp to reduce the risk of dropping and damaging them.
  • 조치
    Identify affected batteries: they have part number 0146-00-0097 and were distributed from 12 December 2011 to 9 November 2016.Maquet’s Field Safety Notice (FSN) advises users not to take spare batteries when transporting the IABP until they receive a re-usable transport and storage case.Until the cases are available use an inverter and a transport AC power supply instead of carrying spare batteries.If these power supplies are not available, carry out an individual risk assessment for the continued use of the devices with batteries whilst in transport.Contact Maquet to acknowledge receipt of the FSNArrange for Maquet to provide (free of charge) warning labels to be applied to batteries and re-usable battery transport and storage cases.

Device

CARDIOSAVE Hybrid intra-aortic balloon pump (IABP) and CARDIOSAVE Rescue IABP
  • 모델명 / 제조번호(시리얼번호)
  • Manufacturer
    Maquet

Manufacturer

Maquet
  • 제조사 주소
    Hari Rajendran, Regulatory Affairs Officer, Maquet Ltd Tel: 0191 519 6200Email hariraj.rajendran@getinge.com
  • 제조사 모회사 (2017)
    Getinge AB
  • Source
    MHRA