Events

Lung ventilators 를 위한 안전성 경고 / 현장 안전성 서한

Medicines and Healthcare products Regulatory Agency에 따르면, 해당 안전성 경고 / 현장 안전성 서한 는 United Kingdom 에서 ResMed 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
    2017-09-12
  • 사례 출판 날짜
    2017-09-12
  • 사례 국가
    United Kingdom
  • 사례 출처
    MHRA
  • 사례 출처 URL
    https://www.gov.uk//drug-device-alerts/lung-ventilators-astral-100-100sc-and-150-potential-power-loss-due-to-faulty-battery
  • 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
    ResMed’s actions:alternative batteries have been developed. Affected batteries are not being recalled.
    batteries will be replaced within the 2-year maintenance period, prioritised according to need. Customers who are concerned about the clinical need of their patients should contact ResMed directly.
    updating the user and clinical guides to advise on the safe use of Astral ventilators when not on AC power.The internal battery is designed to deliver continuous power when the external power source is disrupted.
    It is not intended to serve as a primary power source.Although both internal and external batteries are potentially affected, using both at the same time reduces the risk of power loss as it is highly unlikely that both sets of batteries will fail at the same time.Manufacturer contactsResMed (UK) Ltd
    Tel: 01235 862 997 Option 3
    Email: astralbatterysupport@resmed.com
  • 원인
    Manufactured by resmed – if operated only by the internal battery and this fails, the patient will not be ventilated.
  • 조치
    Identify affected ventilators. Have systems in place to ensure that: users, including patients and carers, understand the problem detailed in the manufacturer’s Field Safety Notice follow the manufacturer’s advice an external battery is connected if the ventilator is used as a mobile unit an additional external power source and backup source of ventilation is available at all times once available, the warning sticker is put on affected ventilators ventilators and external batteries are returned to a service centre for routine maintenance when prompted Return the Field Safety Notice acknowledgement form to ResMed.

Device

Lung ventilators
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    All internal, external and spare batteries are potentially affected by this problem. The RPSII battery is not affected.
  • Manufacturer
    ResMed

Manufacturer

ResMed