Events

Lucas external cardiac compressor 를 위한 안전성 경고 / 현장 안전성 서한

Medicines and Healthcare products Regulatory Agency에 따르면, 해당 안전성 경고 / 현장 안전성 서한 는 United Kingdom 에서 Jolife AB 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
  • 사례 ID
    MDA/2007/013
  • 사례 연번
    CON2030218
  • 날짜
    2007-02-06
  • 사례 국가
    United Kingdom
  • 사례 출처
    MHRA
  • 사례 출처 URL
    https://webarchive.nationalarchives.gov.uk/20141206095400/http://www.mhra.gov.uk/PrintPreview/PublicationSP/CON2030218
  • 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
    The mhra has received reports of: inadequate ventilation in non-intubated patients thoracic cage and lung damage raised levels of atmospheric oxygen in ambulances where the device is powered by an oxygen supply.
  • 조치
    Ensure that all users of this device are aware of the ventilation update to the instructions for use from Jolife AB, appended to this Alert. This now states that when used in non-intubated patients the device can be safely stopped to allow intermittent manual ventilation. Ensure the device is placed correctly, according to its instructions for use (IFU). If the device is powered by oxygen and used in confined spaces (e.g. ambulances) ensure there is adequate ventilation. In ambulances always run the ventilation at the highest capacity and do not recirculate the air. If the device is powered by oxygen always ensure there is an adequate oxygen supply for both the Lucas device and the patient’s respiratory requirements.

Device

Lucas external cardiac compressor
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Lucas external cardiac compressor, manufactured by Jolife AB and distributed by Medtronic Ltd. The Lucas external cardiac compressor is used for external cardiac chest compressions on adult patients who have acute circulatory arrest. The manufacturer defines this as the absence of spontaneous breathing, no pulse and the loss of consciousness. This device is only intended for temporary use where manual resuscitation would otherwise be used. The model of device presently used in the UK, with serial numbers up to and including 14063999, is powered by either oxygen or medical air from the wall outlets of hospitals and ambulances, or from cylinders. This model was manufactured up to May 2006 and uses IFU 100081-00 Rev B. Copies of the device’s instructions for use and its ventilation update, are available from the manufacturer’s website www.lucascpr.com/lucas.php?sid=9 (external link) Device users should ensure they use the appropriate instructions for their device, as there is a new model with serial numbers from 14064000 which is powered by medical air only.
  • Manufacturer
    Jolife AB

Manufacturer

Jolife AB
  • 제조사 모회사 (2017)
    Stryker
  • Source
    MHRA