Events

Retiro De Equipo (Recall) de LifeVest Wearable 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 Zoll Manufacturing Corp..

¿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
    78926
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0353-2018
  • Fecha de inicio del evento
    2017-09-12
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=160876
  • 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
    Wearable automated external defibrillator - Product Code MVK
  • Causa
    Incorrect service code for properly catching critical defects during self-check. potential for defibrillation shock failure.
  • Acción
    On September 14, 2017, ZOLL Manufacturing Corporation issued a patient safety alert notice dated September 12, 2017 to all active patients via courier service. As of November 2, 2017, a copy of this same patient Safety Alert notice is included with all current device shipments. The purpose of the communication is to revise the training patients received about the "Call for service" message. In certain cases, a "Call for service - Message Code 102" could mean that your LifeVest may not be able to deliver therapy if you need it. Users should call ZOLL immediately for a replacement LifeVest if a "Call for service - Message Code 102" appears on the screen. A replacement will be provided within 24 hours. Patients are instructed to continue using the LifeVest as prescribed by their physician.

Device

LifeVest Wearable Defibrillator
  • Modelo / Serial
    All Serial Numbers
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    US Nationwide
  • Descripción del producto
    LifeVest Wearable Defibrillator Model 4000, Product Number 10A0988-A01. || The LifeVest system is indicated for patients 18 years of age and older who are at risk for sudden cardiac arrest and are not candidates for or refuse an implantable defibrillator.
  • Manufacturer
    Zoll Manufacturing Corp.

Manufacturer

Zoll Manufacturing Corp.
  • Dirección del fabricante
    Zoll Manufacturing Corp., 121 Gamma Dr, Pittsburgh PA 15238-2919
  • Empresa matriz del fabricante (2017)
    Zoll Manufacturing Corporation
  • Source
    USFDA