Events

Retiro De Equipo (Recall) de Device Recall The LIFEPAK 15 monitor/defibrillator

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 Physio-Control, 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
    75743
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0761-2017
  • Fecha de inicio del evento
    2010-03-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-12-16
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151125
  • 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
    Automated external defibrillators (non-wearable) - Product Code MKJ
  • Causa
    Customer complaint was received relating to a lifepak15 device that would power on then power down unexpectedly after a short period of use. when the lp15 powered down, power could be immediately restored by activation of the power button. the device was connected to a cellular modem from multitech systems for use with life net services. the corrective action was completed by velocitor solutions in december 2010.
  • Acción
    Velocitor initiated this field action and notified affected customers on March 11, 2010. This action was reported to Physio-Control as completed on 12/21/2010.

Device

Device Recall The LIFEPAK 15 monitor/defibrillator
  • Modelo / Serial
    This action was taken by Velocitor Solutions to notify their customers in 2010. The consignee list was not provided to Physio-Control.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    worldwide
  • Descripción del producto
    The LIFEPAK 15 monitor/defibrillator is intended for use by trained medical || personnel in outdoor and indoor emergency care settings within the environmental conditions specified. Product Part Numbers V-15-2-000XXX
  • Manufacturer
    Physio-Control, Inc.

Manufacturer

Physio-Control, Inc.
  • Dirección del fabricante
    Physio-Control, Inc., 11811 Willows Rd NE, Redmond WA 98052-2003
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    USFDA