Events

HeartStart MRx Defibrillator - Models M3535A, M3536A - Registration 10216710136 - Serial Numbers - See Annex (http://migre.me/9GSbs). 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Philips Medical Systems Ltda. 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
  • 사례 ID
    1148
  • 날짜
    2012-06-29
  • 사례 국가
    Brazil
  • 사례 출처
    ANVISA
  • 사례 출처 URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • 비고 / 경고
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 Brazil.
  • 데이터 추가 비고
    When HeartStart MRx Defibrillator Monitors are used in external transport and in SEM environments, the electrical / mechanical connection (pin plugs and / or port pins) between the patient electrode / blade cable (including the CPR therapy cable and the cable of the external electrodes) and the MRx patient connection port may have higher than expected voltage levels, accelerating wear. Without periodic routine inspections and user-initiated preventive actions, wear of the connection may prevent the device from identifying the connection to a patient electrode / blade cable. Such wear may also cause the MRx to inappropriately identify the patient cable from the external or internal paddles and electrodes.
  • 원인
    The patient cable of the electrodes / paddles and the patient connection port may pose risks to patients and / or health care professionals.
  • 조치
    Carefully read the Appendix - HeartStart MRx Instructions for Use. Immediately perform continuous inspection of the connections of all your MRx devices to detect wear at higher than expected voltage levels. The Annex - HeartStart MRx Instructions for Use describes how a wearer can identify wear. If wear is detected, immediately remove the affected devices and contact Philips to arrange maintenance. NOTICE: The life of your patient / external electrode cables is up to three years. To maintain reliable performance and reduce the possibility of failure during patient use, replace such parts every three years from the time they were put into service or if they do not meet the criteria set out in the Annex - use. (http://migre.me/9GSkE)

Device

HeartStart MRx Defibrillator - Models M3535A, M3536A - Registration 10216710136 - Serial Numbers ...

Manufacturer

Philips Medical Systems Ltda.
  • 제조사 모회사 (2017)
    Philips
  • Source
    ANVSANVISA