Events

IntelliVue patient monitors used with 12-lead ECG 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 Healthcare 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 연번
    MDA/2017/031
  • 날짜
    2017-09-28
  • 사례 출판 날짜
    2017-09-28
  • 사례 국가
    United Kingdom
  • 사례 출처
    MHRA
  • 사례 출처 URL
    https://www.gov.uk//drug-device-alerts/intellivue-patient-monitors-used-with-12-lead-ecg-risk-of-ecg-trace-distortion-specific-models-and-software-versions-affected
  • 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 healthcare: error messages reporting a damaged or incorrectly functioning cable can trigger automatic corrective filtering of the ecg trace, distorting the st segment, leading to risk of misinterpretation or misdiagnosis. (mda/2017/031).
  • 조치
    Identify affected devices, which are listed in the Field Safety Notice. Ensure that users understand and follow the instructions in the Field Safety Notice, in particular, the advice for correctly responding to ‘ECG Check Cable’ or ‘ECG Noisy Elec xx’ error messages. Ensure a Philips Healthcare representative arranges to install the software upgrade as soon as it becomes available. Contact Philips Healthcare to acknowledge receipt of the Field Safety Notice as soon as possible.

Device

IntelliVue patient monitors used with 12-lead ECG

Manufacturer

Philips Healthcare
  • 제조사 주소
    Manufacturer contacts Philips Customer Care Service Centre Tel: 0870 532 9741claudia.romagnuolo@philips.com
  • 제조사 모회사 (2017)
    Philips
  • Source
    MHRA