Events

Internal defibrillator blades and cables used with the LIFEPAK 9, LIFEPAK 9P, LIFEPAK 12 and LIFEPAK 20 Defibrillators / Monitors manufactured by Physio-Control in the United States and marketed in Brazil by Medtronic Comercial Ltda. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Physio-Control Inc - Estados Unidos. Medtronic Comercial Ltda - Rua Joaquim Floriano, 100 - 7º andar - Itaim Bibi - CEP: 04534-000 - São Paulo - SP. e-mail: medtronic.brasil@medtronic.com 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
    914
  • 날짜
    2008-05-05
  • 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
    The product registration holder in Brazil, Medtronic Comercial Ltda, will send the revised Sterilization Protocol to its customers as soon as it is received from the manufacturer. In the meantime, Medtronic Comercial Ltda is kindly requested to circulate this information to the users of your sterilization department. The Safety Notification prepared by Medtronic Comercial Ltda can be found at: http://www.anvisa.gov.br/tecnovigilancia/alertas/anexos_2008/alerta_914_carta.pdf The Protocol of Confirmation of Receipt of Correspondence is available at: http: //www.anvisa.gov.br/tecnovigilancia/alertas/anexos_2008/alerta_914_protocolo.pdf The list of distribution of the products in national territory can be viewed at: http://www.anvisa.gov.br/tecnovigilancia/alertas/ annexes_2008 / alerta_914_produtos.pdf For any additional questions related to this action, please contact the Company Technical Support by phone: (11) 2182-9200.
  • 원인
    Recent tests on sterilization methods have required the manufacturer to modify the instructions for use of these devices and recommend changes in the sterilization methods listed on the current labels. physio-control informs that it has received complaints, but there have been no events with patients or users due to damage or corrosion of the blades or cables. in addition, no infection reports were reported. however, corrosion or damage to the blades or cable may result in the inability to provide the therapy.
  • 조치
    The company directs that the following modifications be observed: DO NOT USE: 1. Gravitational Flash type steam sterilization (validation of adequate sterilization effectiveness has not been achieved); 2. Ethylene Oxide (EO) 12/88 (sterilization by EO 12/88 was withdrawn and replaced by sterilization at 100% OE); 3. STERRAD 100 equipment (STERRAD 100 has been replaced by STERRAD 100S equipment); 4. Gravitational Vapor (Effective, but not recommended, because constant cycles can damage the cables). USE: 1. 100% OE; 2. Equipment STERRAD 100S; 3. Pre-Vacuum Steam. Physio-Control recommends that cables, blades, and connectors should be examined prior to each use and after sterilization for damage or signs of use such as weak connections, damaged connectors, exposed wires, and corrosion of the connector cable. It is also recommended to carefully evaluate the presence of scratches, marks or splinters on blades and also bubbles or splinters on the epoxy cover. In the event of damage, immediately remove the product from use.

Device

Internal defibrillator blades and cables used with the LIFEPAK 9, LIFEPAK 9P, LIFEPAK 12 and LIFE...

Manufacturer

Physio-Control Inc - Estados Unidos. Medtronic Comercial Ltda - Rua Joaquim Floriano, 100 - 7º an...
  • Source
    ANVSANVISA