Events

V60 ventilator 를 위한 안전성 경고 / 현장 안전성 서한

Medicines and Healthcare products Regulatory Agency에 따르면, 해당 안전성 경고 / 현장 안전성 서한 는 United Kingdom 에서 Philips Respironics 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
    2017-05-17
  • 사례 출판 날짜
    2017-05-17
  • 사례 국가
    United Kingdom
  • 사례 출처
    MHRA
  • 사례 출처 URL
    https://www.gov.uk//drug-device-alerts/v60-ventilator-potential-for-unexpected-shutdown
  • 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 philips respironics – faulty software can cause false alarms for stalled blower motor, leading to unexpected shutdown.
  • 조치
    Identify all devices with software version 2.20 (which may have been upgraded by some customers between 17 April 2016 and 4 January 2017) as per Philips’s FSN 86600036A. Ensure either hospital biomedical engineers or Philips field service engineers install the correct software (version 2.10). Philips advise in their FSN that devices with software version 2.20 should not be used unless close clinical observation is available. If alternative devices are unavailable, carry out an individual risk assessment for the continued use of the devices with version 2.20 software until version 2.10 can be installed. Contact Philips Respironics to acknowledge receipt of the FSN.

Device

V60 ventilator

Manufacturer

Philips Respironics
  • 제조사 주소
    Mr Michael Turvey Q&R Officer Philips Health Systems Telephone: 0870 532 9741Email: michael.turvey@philips.com
  • 제조사 모회사 (2017)
    Philips
  • Source
    MHRA