Events

Retiro De Equipo (Recall) de Device Recall HamiltonG5 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 Hamilton 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
    58014
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1928-2011
  • Fecha de inicio del evento
    2011-02-16
  • Fecha de publicación del evento
    2011-04-08
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-03-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97973
  • 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
    Facility Use Continuous Ventilator - Product Code CBK
  • Causa
    The adaptive volume/pressure regulation can be automatically and permanently reduced to peep + 3 mbar when a closed suctioning maneuver is performed on the patient and may be undetected by the operator.
  • Acción
    A Medical device Safety Alert and Corrective Action along with a cover letter, was sent to all locations on February 16, 2011. The letter identified the affected product along with the reason for recall. The letter states that operators deactivate the "high tidal volume" alarm as described in appendix K.4 of the operator's manual until the ventilator is upgraded with a corrected software. Distributors will upgrade the affected devices with the corrected software as soon as possible. Questions can be directed to 800-426-6331, ext 215.

Device

Device Recall HamiltonG5 Ventilator
  • Modelo / Serial
    Software version V2.00x and Neonatal Option or V2.01x and Neonatal software
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution -- MA, FL, GA, NC, MI, NC, MO, TX, and WV.
  • Descripción del producto
    Hamilton-G5 Ventilator with software version V2.00x and Neonatal Option or V2.01x and Neonatal software. Hamilton-G5: catalog number 159001; || Neonatal Software catalog number: 159700; Neonatal Option catalog number: 159187. Hamilton Medical || Intended for use in the hospital and institutional environment where healthcare professionals provide patient care.
  • Manufacturer
    Hamilton Medical Inc

Manufacturer

Hamilton Medical Inc
  • Dirección del fabricante
    Hamilton Medical Inc, 4990 Energy Way, P O Box 30008, Reno NV 89502-3008
  • Empresa matriz del fabricante (2017)
    Hamilton Bonaduz Ag
  • Source
    USFDA