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
    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/defibrillators medical device manufacturer, philips healthcare, has issued a field safety notice concerning heartstart mrx monitor/defibrillator. the affected model numbers and serial numbers are as follows: m3535a: us00100104 - us00572207 m3536a: us00100902 - us00543688 m3536j: us00209838 - us0332675 m3536m: us00500002 - us00500009 m3536mc: us00500002 - us00500028 when used in hospital transport and pre-hospital environments, the connection between the pads/paddles therapy cable (including pads cpr therapy cable, external paddles cable, and internal paddles cable/adapter) and the mrx therapy connection port could experience high levels of stress causing accelerated wear. wear of the connection could prevent the device from sensing that the pads/paddles therapy cable is connected. this wear could also cause the affected product to inappropriately identify the pads therapy cable, external paddles, or internal paddles. pads/paddles therapy cable and therapy connection port wear could pose a risk for patients and/or caregivers. the manufacturer will arrange inspection of the affected units and install a stabilizing collar if necessary. the manufacturer advises healthcare professionals that the affected product can continue to be used prior to receiving the hardware update. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 26 february 2014.

Device

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

Manufacturer

  • 제조사 모회사 (2017)
  • Source
    DH