Events

Alerta De Seguridad para Non-rechargeable Lithium Batteries used with Lifepak 500 Automated External Defibrillators (Nonrechargeable Lithium Batteries used with Lifepak 500 Automated External Defibrillators). Identifier: Parts Nos .: (1) from 3005380-000 to 3005380-006, (2) 3005380-014; Date Codes: (1) from 9837 to 9920, (2) 9812, from 9901 to 9905 within Medtronic Physio-Control

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Medtronic Physio-Control Corp.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    283
  • Fecha
    2000-09-29
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    To date, the existence of 02 registrations of said product in Brazil on behalf of the Companies, UNITED MEDICAL LTDA and MEDTRONIC COMERCIAL LTDA, has been detected. BRASIL - 15.01.2002 - The Company UNITED MEDICAL LTDA, further sells said product, and is finalizing the process of requesting cancellation of registration with ANVISA. BRAZIL - 25.07.2002 - The company MEDTRONIC COMERCIAL LTDA, reports that 46 units were imported, and only 24 units belong to the lot / series that presented problems (30.01.2002). In addition, all replacements and upgrades have been successfully completed.
  • Causa
    Medtronic physio-control received 6 reports of battery failure caused by battery cell rupture. medtronic physio-control stated that each failure involved the rupture of only one battery which led to the opening / rupturing of the packaging box. two of the six reports said that this rupture caused minor injuries to the defibrillator operator, including respiratory irritations and first-degree burns. medtronic physio-control initiated a correction by correspondence dated july 10, 2000.
  • Acción
    Make sure that you have received the July 10, 2000 correspondence and Medtronic Physio-Control replacement batteries. Identify the affected product by removing the battery from the Lifepak 500 automated external defibrillator (AED) to check the part number and date code. If the battery number does not match the numbers of the affected batteries, the battery can be reinstalled. If the battery number matches the affected battery numbers, remove it from use and install a new battery supplied by Medtronic Physio-Control. After installing the new battery, turn the AED on to advise the unit that a new battery has been installed. After 10 seconds, make sure the message "Connected Electrodes" appears. The unit is ready for use. The company estimates that the recall date for this recall is September 30, 2000. For more information, contact your Medtronic Physio-Control representative or technical support at (1-425) 867-4000 in the United States

Device

Non-rechargeable Lithium Batteries used with Lifepak 500 Automated External Defibrillators (Nonre...

Manufacturer

Medtronic Physio-Control Corp
  • Source
    ANVSANVISA