Events

Retiro De Equipo (Recall) de Device Recall The HAMILTON T1

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
    64117
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-0741-2013
  • Fecha de inicio del evento
    2012-12-19
  • Fecha de publicación del evento
    2013-01-31
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-04-22
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115383
  • 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
    Analysis of a customer complaint has shown that during ventilation of small pediatric patients with high airway resistance and low lung compliance, the oxygen consumption of a hamilton t1 ventilator with software versions 1.1.2 and lower must be calculated using a larger margin than originally expected.
  • Acción
    Hamilton sent a Field Safety alert letter dated January 11, 2013 to all customers. The letter identified the affected product, explained the potential problem and a included Medical Device Safety Alert and Corrective Action document. Hamilton is working on a new software version for this issue. Customers are asked to update their operator manual with the update oxygen consumption formula page which provided revised information for calculating oxygen capacity. When the new software is available, Hamilton will provide loaner devices to each location while their unit is being upgraded. Questions should be addressed to Hamilton Medical at 800-426-6331 ext 215

Device

Device Recall The HAMILTON T1
  • Modelo / Serial
    Software Versions 1.1.2 and below; Part numbers 161005, 161006.
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Nationwide Distribution including the country of Switzerland.
  • Descripción del producto
    HAMILTON-T1 Ventilator with software versions 1.1.2 or lower. || The HAMILTON T-1 Ventilator is intended to provide positive pressure ventilatory support to adults and pediatrics
  • Manufacturer
    Hamilton Medical Inc

Manufacturer

Hamilton Medical Inc
  • Dirección del fabricante
    Hamilton Medical Inc, 4990 Energy Way, P O Box 30008, Reno NV 89502-4123
  • Empresa matriz del fabricante (2017)
    Hamilton Bonaduz Ag
  • Source
    USFDA