Events

MONITORING AND DEFIBRILLATION SYSTEM LIFEPACK 12 - LIFEPACK 20 DEFIBRILLATOR AND LIFEPACK 9P MONITORING AND DEFIBRILLATION SYSTEM - Registered at ANVISA under the numbers 10339190080 - 10339191171 and 10339190082 - respectively. LOTS AFFECTED - according to the list attached to this Alert. http://en.wikipedia.org/w/index.php?? 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
    1019
  • 날짜
    2010-05-17
  • 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
    Receipt of this information occurs because company records indicate that your organization has purchased internal paddles used in the LIFEPAK defibrillators / monitors listed above. If you no longer use these accessories, your organization is not affected. The company established a schedule of action until June / 2010 for the communication of its clients - letter attached to this Alert - July / 2010 for regularization of the petition with Anvisa and August / 2010 for the conclusion of the process. Anvisa is following this case.
  • 원인
    Physio-control, inc., a division of medtronic, inc. has updated the sterilization guide for internal defibrillator / monitor blades: lifepak®9, lifepak 9p, lifepak 12, lifepak 20 or lifepak 20e by removing ethylene oxide from the method sterilization. recommended methods are sterrad® 100s equipment and pre-vac steam.
  • 조치
    For organizations that use the internal defibrillator paddles listed above, the Sterilization Guide should be replaced for all of these accessories. We recommend that a copy of this notice be forwarded to the sterilization departments. Attached to this information is being provided the new sterilization guide (in Portuguese). The Physio-Control division is committed to ensuring that all customers are always assisted. Please contact technical support on 011-2182-9200 for any additional questions related to this action.

Device

MONITORING AND DEFIBRILLATION SYSTEM LIFEPACK 12 - LIFEPACK 20 DEFIBRILLATOR AND LIFEPACK 9P MONI...

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