HeartStart MRx Monitor/Defibrillator 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Philips Medical Systems 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert
  • 날짜
    2014-02-26
  • 사례 출판 날짜
    2014-02-26
  • 사례 국가
  • 사례 출처
    DH
  • 사례 출처 URL
  • 비고 / 경고
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • 데이터 추가 비고
    Medical Device Safety Alert
  • 원인
    Medical device safety alert: philips heartstart mrx monitor/defibrillator medical device manufacturer, philips healthcare, has issued a field safety notice (fsn) concerning heartstart mrx monitor/defibrillator. the affected model numbers are m3535a, m3536a, m3536j, m3536m, m3536m5, and m3536mc, and the affected serial numbers are within the range us00100100 - us00550668. the ecg trunk cable and connector block of the mrx could be susceptible to accelerated wear, which could result in an interrupted ecg signal. interruption of the ecg signal can cause loss of demand mode pacing, inability to perform synchronized cardioversion with paddles, and disruption of leads ecg monitoring, which could delay appropriate treatment. defibrillation, fixed mode pacing, ecg monitoring via pads/paddles, and other monitoring functions are not impacted by this issue. the manufacturer will provide a hardware upgrade on all affected units. users can continue to use mrx prior to receiving the hardware upgrade. if the above problem occurs, users should refer to the heartstart mrx instructions for use for troubleshooting assistance and follow the technical advice as listed in the fsn. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 26 february 2014.

Device

  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Philips Medical Systems HeartStart MRx Monitor/Defibrillator
  • Manufacturer

Manufacturer

  • 제조사 모회사 (2017)
  • Source
    DH