Events

Retiro De Equipo (Recall) de Device Recall Portable Critical Care Ventilator

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 Medical 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
    79248
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0812-2018
  • Fecha de inicio del evento
    2017-06-30
  • 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=161746
  • 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
    Ventilator, continuous, facility use - Product Code CBK
  • Causa
    A software anomaly in the 731 software version 05/20/00, was identified, which can lead to a user inadvertently changing device settings.
  • Acción
    On June 30, 2017 an urgent recall letter was mailed to customers with the following instructions: Customers who have affected devices should immediately take the following steps: (1) Alert all users of 731 Ventilator models to this problem. (2) Direct users to always verify device parameters after selecting the device Confirm button. (3) Contact ZOLL's Technical Service Department or your local ZOLL Service Provider to schedule a software update for affected devices Our 24/7 technical support numbers 1(800) 348-9011 or +l (978) 421- 9460 are available to assist users with any aspect of this notice.

Device

Device Recall Portable Critical Care Ventilator
  • Modelo / Serial
    Models EMV+, AEV, Eagle II,and Eagle II MRI
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Outside US
  • Descripción del producto
    731 Series Ventilators running software version 05.20.00 || The devices in the ZOLL ventilator are indicated for use in the management of infant through adult patients weighing ;:: 5 kg with acute or chronic respiratory failure or during resuscitation by providing continuous positive-pressure ventilation. They are appropriate for use in hospitals, outside the hospital, during transport and in severe environments where they may be exposed to rain, dust, rough handling, and extremes in temperature and humidity. With an appropriate third-party filter in place, they may be operated in environments where chemical and/or biological toxins are present. When marked with an MRI conditional label, they are suitable for use in an MRI environment with appropriate precautions. The ventilators are intended for use by skilled care providers with knowledge of mechanical ventilation, emergency medical services (EMS) personnel with a basic knowledge of mechanical ventilation, and by first responders under the direction of skilled medical care providers. The EMV+¿ and Eagle II (with and without MRI label) have a full range of ventilation modes (AC, SIMV with or without PS, CPAP with or without PS with PPC or NPPV-PPV). The AEV¿ provides specific modes consistent with pre-hospital care provider s operating procedures (AC, CPAP with PS and NPPV-PPV). The ZOLL ventilators are a small, extremely durable, full-featured portable mechanical ventilator designed to operate in hospitals or severe and under-resourced environments. It can be used in prehospital (ALS, ATLS, ACLS), field hospitals, and hospital settings. Easy¿ to-use, durable,
  • Manufacturer
    ZOLL Medical Corporation

Manufacturer

ZOLL Medical Corporation
  • Dirección del fabricante
    ZOLL Medical Corporation, 269 & 271 Mill Road, Chelmsford MA 01824
  • Empresa matriz del fabricante (2017)
    Asahi Kasei Corp.
  • Source
    USFDA