Events

SureSigns VS & VM patient monitors and Viewing stations manufactured before May 2018 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 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
    2018-09-19
  • 사례 출판 날짜
    2018-09-19
  • 사례 국가
    United Kingdom
  • 사례 출처
    MHRA
  • 사례 출처 URL
    https://www.gov.uk//drug-device-alerts/suresigns-vs-vm-patient-monitors-and-viewing-stations-manufactured-before-may-2018-risk-of-batteries-overheating-or-igniting-mda-2018-031
  • 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
    Philips have received reports of their SureSigns monitors with lithium ion batteries overheating or igniting when exceeding their three-year service interval or reaching 300 charge-discharge cycles. The current labelling and instructions for use (IFU) do not provide full instructions on when to replace the batteries. As a result, Philips are issuing an updated IFU and software upgrade to provide system warnings in aid of managing the battery replacement cycle.
  • 원인
    Manufactured by philips – lithium ion batteries which have exceeded their specified replacement interval or number of charging cycles are at risk of overheating or igniting.
  • 조치
    Identify all affected devices (see manufacturers’ Field Safety Notice (FSN)). Check whether the battery has exceeded its’ three-year replacement interval or has reached 300 charge-discharge cycles in line with the FSN. Refer to the Philips SureSigns VS & VM monitors and View station Service Guide for details on how to replace the battery if required. Contact Philips to order replacement batteries. Ensure that there are systems in place to routinely check battery life until the software update is made available (November 2018) and installed. Contact Philips to confirm receipt of their FSN using their response form. Report adverse events involving these devices through your local incident reporting system and/or your national incident reporting authority as appropriate: England, Scotland, Northern Ireland, Wales. You should also report directly to manufacturers if your local or national systems do not.

Device

SureSigns VS & VM patient monitors and Viewing stations manufactured before May 2018
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Images of SureSigns VS & VM patient monitors and Viewing stations
  • Manufacturer
    Philips

Manufacturer

Philips
  • 제조사 주소
    Philips Customer Care Service Centre Telephone: 0870 532 9741Email: DeviceVigilanceUKI@Philips.com.
  • 제조사 모회사 (2017)
    Philips
  • Source
    MHRA