Events

Pagewriter Cardiographs (TC20/30/50/70) manufactured before 20 November 2018 and Efficia Monitors (CM10/12/100/120/150) manufactured before 25 October 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
    2019-03-20
  • 사례 출판 날짜
    2019-03-20
  • 사례 국가
    United Kingdom
  • 사례 출처
    MHRA
  • 사례 출처 URL
    https://www.gov.uk//drug-device-alerts/pagewriter-cardiographs-tc20-30-50-70-manufactured-before-20-november-2018-and-efficia-monitors-cm10-12-100-120-150-manufactured-before-25-october-2018-risk-of-batteries-overheating-or-igniting-mda-2019-017
  • 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
    Manufactured by Philips – this problem affects lithium ion batteries that have exceeded their specified replacement interval or number of charging cycles.
  • 원인
    Manufactured by philips – this problem affects lithium ion batteries that have exceeded their specified replacement interval or number of charging cycles.
  • 조치
    Identify all affected devices using the manufacturer's Field Safety Notices (FSNs) for the TC Cardiograph and the Efficia monitor.Contact Philips to confirm receipt of each FSN using their response form.For TC Cardiographs: Check if the battery has exceeded 300 charge-discharge cycles or if the battery state of health is less than 80%. If necessary, replace the battery in accordance with the instructions in the FSN. Contact Philips to order replacement batteries. Ensure that systems are in place to routinely assess battery condition. Philips are developing a software update that will assist in battery management and will contact you once this is available. For Efficia Monitors: Install the software update (version A.01.11) described in the FSN Once installed, the device will indicate via an error message if battery replacement is necessary. Contact Philips to order replacement batteries. 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

Pagewriter Cardiographs (TC20/30/50/70) manufactured before 20 November 2018 and Efficia Monitors...
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Problem/backgroundPhilips have received reports of lithium ion batteries overheating and igniting when they exceed 300 charge/discharge cycles or when battery capacity fell below 80% that of a new battery. The device can display actual information on the battery state of health and charge-discharge cycles. However, the existing labelling does not include full instructions on how to use this information to determine when to replace the battery.A previous medical device alert MDA/2018/0031 was published for the same issue in Philips Suresigns VS and VM patient monitors and viewing stations manufactured before the 03 May 2018. If you have these devices, please ensure that the actions described in that MDA have been completed.
  • Manufacturer
    Philips

Manufacturer

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