Events

Retiro De Equipo (Recall) de Device Recall SERVO Ventilator 300A

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 MAQUET 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
    50676
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0872-2009
  • Fecha de inicio del evento
    2008-12-19
  • Fecha de publicación del evento
    2009-02-03
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2009-07-08
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=75975
  • 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
    Servo ventilator 300a could cause hypoventilation if the use of the pc or prvc mode with the automode function set to "on" in neonatal and pediatric patient ranges with small tidal volumes and short set inspiratory rise time.
  • Acción
    URGENT: Device Correction letters were sent out on December 22, 2008. Letters alert users to the potential problem and the situation in which it may occur. Letter indicate the set inspiratory rise time should be set in the range of 7-10% and that the humidifier chamber water level be maintained according to manufacturers instructions. The letter is enclosed as a supplement to the SV300A Operating Manual. Consignees were directed to complete a "Device Correction-Customer Fax Response" to indicate number of units of the affected product and that they followed the instructions for including the attached supplemental instructions to the operating manual. For questions about the recall, contact your local Maquet, Inc. representative.

Device

Device Recall SERVO Ventilator 300A
  • Modelo / Serial
    All units of SV300A.
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide
  • Descripción del producto
    SERVO Ventilator 300A (SV300A); || Maquet Critical Care Ab, Solna, Sweden. || The device is intended for general and critical ventilatory care of adult, pediatric, infant and neonatal patients. The unit is designed to be used at the bedside and for intra-hospital transport. It is not intended for transport use in ambulances or in helicopters in the US market.
  • Manufacturer
    MAQUET Inc.

Manufacturer

MAQUET Inc.
  • Dirección del fabricante
    MAQUET Inc., 1140 Us Highway 22 Ste 202, Bridgewater NJ 08807-2958
  • Empresa matriz del fabricante (2017)
    Getinge AB
  • Source
    USFDA