heartstart mrx monitor/defibrillators 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Philips Healthcare 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
    2013-06-14
  • 사례 출판 날짜
    2013-06-14
  • 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/defibrillators medical device manufacturer, philips healthcare, has issued a medical device safety alert concerning certain models of heartstart mrx monitor/defibrillators [model no.: m3535a, m3536a, m3536j, m3536m, m3536mc, m3536m2, m3536m4, m3536m5 and m3536m6]. the affected units include those manufactured by philips between february 2004 and february 2013, and shipped worldwide with serial numbers within the ranges us00100100 and us00565942. a philips heartstart mrx monitor/defibrillator operating on battery power only that is used in-hospital or in pre-hospital environments may shutdown without warning if exposed to elevated levels of electromagnetic interference from other radio frequency (rf) energy sources and continuous repetitive power line bursts. examples of other equipment that can cause interference are other medical devices, cellular products, information technology equipment and radio/television transmissions. the manufacturer provides the following information and advice the condition can be avoided by operating the device on external ac or external dc power. when using battery power only, users should follow the device instructions to minimize or eliminate potential interference from other rf sources. see mrx ifu section, safety considerations, emissions and immunity for proper use of your mrx relative to electromagnetic emissions. if the device powers down and the battery fuel gauge lights appear off or dim, users should perform the following: remove any potential source of rf interference from the environment replace the battery with a fully-charged battery with five solid, bright green lights on the battery fuel gauge or connect an external power source in addition, the manufacturer will provide an ifu addendum titled "heartstart mrx electromagnetic compatibility" for all customers with affected units. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 14 june 2013.

Device

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

Manufacturer

  • 제조사 모회사 (2017)
  • Source
    DH