Events

Retiro De Equipo (Recall) de Device Recall Carina Home 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 Draeger Medical, 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
    51447
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1263-2009
  • Fecha de inicio del evento
    2009-01-21
  • Fecha de publicación del evento
    2009-05-14
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-01-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=80299
  • 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
    The device may not generate a pilot line disconnect alarm if the pilot line becomes disconnected, which may potentially result in a substantial reduction in tidal volume delivery.
  • Acción
    An "Urgent - Medical Device Recall" Letter dated January 2009 was issued to consignees via certified mail. The letter described the issue, specific conditions, background information, and precautions for customers. An additional letter dated January 22, 2009 was included with the "Urgent - Medical Device Recall" letter which instructed consignees to inform an enduser of the contents of the notification letter because some of the consignees are home care device/service providers. When the new hardware/software solution is available, affected devices will be updated free of charge. Direct questions about the notification letter to Drager Medical, Inc. by calling 1-800-543-5047 (press "1" at the prompt and then press "2349#"). Direct questions regarding updating your device when the new software is available, contact Drager Service Technical Support at 1-800-543-5047 (press "4" at the prompt).

Device

Device Recall Carina Home Ventilator
  • Modelo / Serial
    Catalog Numbers 5704757 and 5704758.
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution -- states of CA, FL, GA, HI, IL, LA, MA, MN, OH, and TX.
  • Descripción del producto
    Carina Home Ventilator. || The device is used as a continuous respirator/ventilator for home use.
  • Manufacturer
    Draeger Medical, Inc.

Manufacturer

Draeger Medical, Inc.
  • Dirección del fabricante
    Draeger Medical, Inc., 3135 Quarry Rd, Telford PA 18969-1042
  • Empresa matriz del fabricante (2017)
    Stefan Dräger GmbH
  • Source
    USFDA