Events

LIFEPAK CR PLUS AUTOMATIC EXTERNAL DEFIBRILLER, Model LIFEPAK CR PLUS, Registration no. 10339190167, Serial no. - see attached list 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Medtronic Comercial 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
    1237
  • 날짜
    2013-03-18
  • 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
    Please note that your defibrillators may be affected by this anomaly and that they should be checked regularly for proper functioning (appliances and batteries) as indicated in the Operating Instructions for as long as they are in their possession. For any questions or concerns, contact the Company's Technical Assistance by e-mail or by calling 11-2187-9212, Monday through Friday, at the following times: 08:30 to 17:30.
  • 원인
    Lifepak cr plus external automatic defibrillators are battery-powered devices and require the batteries to operate and deliver the desired therapy. the charge-pak ™ replaceable battery charger is designed to be replaced approximately every 2 (two) years. in some circumstances, the life of the charge-pak replaceable battery charger has not reached the period of 2 (two) years due to an internal electrical fault that leads to the early exhaustion of the internal battery of the defibrillators. the defibrillator display continues to communicate the status of the device and the battery correctly even if the device is affected by this anomaly.
  • 조치
    The company directs to verify if the serial number of the defibrillator in use in the service is in the relation of the numbers of affected series and requests to follow the instructions contained in the letter to the client: URGENT SAFETY NOTICE - LIFEPAK CR® Plus FSCA - FA260 External Automatic Defibrillators attached to this alert). If the problem is identified, the company's technical assistance should be contacted for collection of the equipment and after returning the defibrillator to Physio-Control for verification, the device will be analyzed to determine if it is affected by the anomaly of early exhaustion the internal battery. If the defibrillator is affected, the company will provide a permanent replacement device.

Device

LIFEPAK CR PLUS AUTOMATIC EXTERNAL DEFIBRILLER, Model LIFEPAK CR PLUS, Registration no. 103391901...

Manufacturer

Medtronic Comercial Ltda
  • 제조사 모회사 (2017)
    Medtronic plc
  • 제조사 의견
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    ANVSANVISA