Events

Retiro De Equipo (Recall) de Battery Pack portion of the LifeVest device

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 Zoll Lifecor Corporation.

¿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
    44942
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0061-2008
  • Fecha de inicio del evento
    2007-09-14
  • Fecha de publicación del evento
    2007-10-18
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-06-13
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=64559
  • 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
    battery - Product Code MVK
  • Causa
    Possible malfunction of the battery pack. a significant electrostatic discharge (esd) can cause the battery pack to malfunction. the malfunction causes the battery pack to discharge more rapidly and prevents the pack from recharging.
  • Acción
    Patients currently using the LifeVest should continue to do so while the product removal is underway. Advisory notices will be sent via first class mail 9/14/2007 to all active patients using the LifeVest device. Product replacements began on 8/31/07 by shipping out revised battery packs for new patient use. Shipments of new battery packs will continue based on production capacity and material availability. Any patients expected to be using the device longer than 5 months will be provided with 2 replacement Battery Packs. They will be instructed to return their existing packs in the same shipping box.

Device

Battery Pack portion of the LifeVest device
  • Modelo / Serial
    Product number 10A0894-A01. Serial numbers 71000101 through 71003176.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    The product was shipped nationwide to patients. The product was also shipped to distributors in Germany, United Kingdom, Italy, Spain, France, and Denmark.
  • Descripción del producto
    Battery Pack portion of the LifeVest device. The LifeVest is a wearable cardioverter defibrillator worn by a patient at risk for sudden cardiac arrest (SCA).
  • Manufacturer
    Zoll Lifecor Corporation

Manufacturer

Zoll Lifecor Corporation
  • Dirección del fabricante
    Zoll Lifecor Corporation, 121 Freeport Rd, Pittsburgh PA 15238-3411
  • Source
    USFDA