Events

Safety Alert for 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.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by 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.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    914
  • Date
    2008-05-05
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the data
    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.
  • Reason
    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.
  • Action
    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