Events

HEARTSTART MRX DEFIBRILLATOR - Models M3535A and M3536A. Anvisa Registry: 10216710136. 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
    1022
  • 날짜
    2010-06-02
  • 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
    According to information presented by Philips Medical Systems Ltd., after two years of continuous use mechanical wear caused by vibration and frequent disconnections may cause an intermittent electrical connection between the battery and the equipment. The power outage during the use of the equipment may cause it to restart with interruption of therapy (monitoring of the electrocardiogram / electric shock for defibrillation of the heart muscle). #### Update (20/06/2012): Philips Medical Systems Ltda informed the UTVIG about the completion of the field action. According to the company, the addendums to the instructions for use were sent to affected customers in Brazil.
  • 원인
    Blinking electrical connection between the battery and the equipment, which may cause the defibrillator to fail.
  • 조치
    The company sent an informative letter to customers, with an addendum to the instructions for use of the equipment (Notice of Application of the Instructions for Use of the Lithium Ion Battery M3538A). It is recommended that all affected batteries be replaced after two years of continuous service, or when the battery capacity calibration fails, whichever comes first. The details of the instructions should be verified in the Letter to Customers (available at http://portal.anvisa.gov.br/wps/wcm/connect/f13aa60042b4e27f8b89cbb134f70e0f/Carta+a++Clients.pdf?MOD=AJPERES) and in the Addendum to Instruction Manual (available at http://portal.anvisa.gov.br/wps/wcm/connect/3b74638042b4e3228b92cbb134f70e0f/Adding+to+Manual+of+Instructions+.pdf?MOD=AJPERES) .

Device

HEARTSTART MRX DEFIBRILLATOR - Models M3535A and M3536A. Anvisa Registry: 10216710136.

Manufacturer

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