Events

HeartStart MRx monitor/defibrillator 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
    2012-08-08
  • 사례 출판 날짜
    2012-08-07
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120808.html
  • 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 health canada posted a medical device safety alert concerning heartstart mrx monitor/defibrillator (model no.: m3535a, m3536a), manufactured by philips medical systems. according to the report, the manufacturer has become aware that affected devices may exhibit the following behaviors: in aed mode the device experiences difficulty interpreting pads ecg waveforms and may incorrectly analyze the waveform (potential for inappropriate therapy) or fail to analyze the waveform. in manual mode the user may have trouble interpreting the pads ecg waveform and determining whether or not to deliver therapy in addition the devive may provide erroneous alarms (e.G. pvc/min high, vtach, asystole) or indicate an asystolic rhythm when paddles are not in patient contact. if cpr meter is in use, users may not get an accurate impedance derived ventilation feedback. for details, please refer to the health canada website http://www.Hc-sc.Gc.Ca/dhp-mps/compli-conform/recall-retrait/ _list/rec-ret_md-im_date_july-sept_2012-eng.Php if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 7 august 2012.

Device

HeartStart MRx monitor/defibrillator
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Philips HeartStart MRx monitor/defibrillator
  • Manufacturer
    Philips Healthcare

Manufacturer

Philips Healthcare
  • 제조사 모회사 (2017)
    Philips
  • Source
    DH