Events

Retiro De Equipo (Recall) de LIFEPAK CR Plus

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Medtronic Emergency Response Systems, Inc..

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    36484
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0836-2007
  • Fecha de inicio del evento
    2006-10-05
  • Fecha de publicación del evento
    2007-06-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-08-08
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48724
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Defibrillator - Product Code MKJ
  • Causa
    Premature battery depletion due to electrical component failure.
  • Acción
    Per request from Japan, the firm initiated action on 10/5/06 replacing the devices in Japan with new devices. On 3/2/07 the firm issued a Safety Alert letter dated February 2007 to consignees (with the exception of Japan), advising that the defibrillators have an identified, lead-free component that is susceptible to failure within the first 250 days after manufacture. Failure of this component might cause a short that will drain the battery and eventually render the device inoperative. The letter further states that the firm strongly recommends that the consignee immediately and on a regular basis, inspect their defibrillator(s) per the LIFEPAK CR Plus/EXPRESS Operating Instructions - Section 5 Caring for the Defibrillator. The letter also provides a website to allow consignees to enter their device serial number(s) to determine if their LIFEPAK CR Plus/LIFEPAK EXPRESS are included in the action. This recall strategy is subject to modification pending the performance of devices remaining on the market.

Device

LIFEPAK CR Plus
  • Modelo / Serial
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Distribution is worldwide. The device is designed for non-professional users and are primarily used in public access defibrillator environments such as airports, schools, and public libraries.
  • Descripción del producto
    LIFEPAK CR Plus defibrillator
  • Manufacturer
    Medtronic Emergency Response Systems, Inc.

Manufacturer

Medtronic Emergency Response Systems, Inc.
  • Dirección del fabricante
    Medtronic Emergency Response Systems, Inc., 11811 Willows Rd Ne, Redmond WA 98052-2003
  • Source
    USFDA