Events

HeartStart MRx defibrillator/monitor 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
  • 사례 ID
    MDA/2014/024
  • 사례 연번
    CON428361
  • 날짜
    2014-06-26
  • 사례 출판 날짜
    2014-06-26
  • 사례 국가
    United Kingdom
  • 사례 출처
    MHRA
  • 사례 출처 URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON428361?tabName=allTabs
  • 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
    Risk of delay in delivering cpr. when the heartstart mrx is used with the q-cpr meter in defibrillation mode, the meter may incorrectly display the ‘do not touch the patient’ icon. consequently, the user might not resume chest compressions in a timely manner, which could affect patient outcome. this problem can occur in aed or manual modes. philips issued a field safety notice dated april 2014 (reference fsn86100128a). when the heartstart mrx is in aed mode, the q-cpr meter is designed to display the ‘do not touch the patient’ icon during the shock advisory analysis period. if the user continues to deliver chest compressions when the shock advisory analysis begins, the ‘do not touch the patient’ icon may incorrectly remain on the screen after analysis or shock delivery is complete. when the heartstart mrx is in manual mode, the q-cpr meter is designed to display the ‘do not touch the patient’ icon when the device is charging to the selected energy. if the clinician continues to provide chest compressions while the device is charging, the q-cpr meter ‘do not touch the patient’ icon may incorrectly remain on the screen after shock delivery is complete. note: the mrx shock advisory decision and shock delivery continue to be executed correctly in all modes in aed mode the mrx continues to re-analyze for the shock advisory decision every two minutes with the exception of cpr meter feedback, all other mrx voice prompts including ‘resume cpr’ and ‘pause, analyzing’ operate as intended.
  • 조치
    Identify any affected devices in your possession, using the Field Safety Notice. You can continue to use your HeartStart MRx without the Q-CPR meter attached. If you use the HeartStart MRx with the Q-CPR meter attached and the Q-CPR meter displays the ‘Do Not Touch the Patient’ icon at an unexpected time, follow the MRx instructions for use and remove the meter from the patient and continue CPR according to local protocol. Philips will contact you to arrange to install the software upgrade.

Device

HeartStart MRx defibrillator/monitor
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    HeartStart MRx defibrillator/monitor. Model numbers M3535A and M3536A with Q-CPR™ meter option B08. Specific serial numbers affected. Affected MRx units have to meet all of the three criteria below: serial numbers from US00100153 to US00571587 inclusive the Q-CPR Meter Option B08 installed Software revision F.xx, R.xx, T.00.00 or T.00.01 installed
  • Manufacturer
    Philips

Manufacturer

Philips
  • 제조사 모회사 (2017)
    Philips
  • Source
    MHRA