HEARTSTART MRX DEFIBRILLATOR/MONITOR 의 리콜

Health Canada (via FOI)에 따르면, 해당 리콜 는 Canada 에서 PHILIPS ELECTRONICS LTD. 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    43736
  • 사례 위험등급
    II
  • 사례 시작날짜
    2014-02-26
  • 사례 국가
  • 사례 출처
    HC
  • 비고 / 경고
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • 데이터 추가 비고
  • 원인
    Philips has become aware of the following issues regarding the heartstart mrx monitor/defibrillator: 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.

Device

  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: M3536A (Lot serial: ALL); Model Catalog: M3535A (Lot serial: ALL); Model Catalog: 861444 (Lot serial: ALL)
  • 제품 설명
    HEARTSTART MRX DEFIBRILLATOR/MONITOR
  • Manufacturer

Manufacturer

  • 제조사 주소
    MARKHAM
  • 제조사 모회사 (2017)
  • Source
    HC