Events

Automatic external defibrillator (AED) LIFEPAK CR Plus and LIFEPAK EXPRESS 를 위한 안전성 경고 / 현장 안전성 서한

Medicines and Healthcare products Regulatory Agency에 따르면, 해당 안전성 경고 / 현장 안전성 서한 는 United Kingdom 에서 Physio-Control 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
    2016-10-13
  • 사례 출판 날짜
    2016-10-13
  • 사례 국가
    United Kingdom
  • 사례 출처
    MHRA
  • 사례 출처 URL
    https://www.gov.uk//drug-device-alerts/automatic-external-defibrillator-aed-lifepak-cr-plus-and-lifepak-express-risk-of-failure-to-deliver-a-shock
  • 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
    LIFEPAK CR Plus AEDs or LIFEPAK EXPRESS AEDs may fail to initiate voice prompts when the ON/OFF button is pressed and the lid is opened. The problem is due to an internal component (reed switch) that can intermittently become fixed in the closed position. A defibrillator in this condition will fail to deliver a shock.
  • 원인
    Manufactured by physio-control – risk of delay to defibrillation due to an intermittent component failure. specific serial numbers are affected.
  • 조치
    Ensure that all those responsible for the AED follow the instructions in the manufacturer’s Field Safety Notice FSN To check if your AED is affected call Physio-Control customer support or visit their website and go to ‘Search Affected Devices’ and enter the serial numbers. If the AED is faulty, remove the unit from service and contact Physio-Control to arrange for it to be corrected. If you have already acted on this FSN, no further action is required.

Device

Automatic external defibrillator (AED) LIFEPAK CR Plus and LIFEPAK EXPRESS
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    The AED can be found in hospitals and in public places (eg railway stations, village halls and supermarkets).
  • Manufacturer
    Physio-Control

Manufacturer

Physio-Control
  • 제조사 주소
    Physio-Control Operations, Netherlands Telephone: 0808 258 0094Email: RS.EMEArecall@physio-control.com
  • 제조사 모회사 (2017)
    Stryker
  • Source
    MHRA