Events

Retiro De Equipo (Recall) de Hamilton C2 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
    66408
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0170-2014
  • Fecha de publicación del evento
    2013-11-06
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2018-03-29
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122352
  • 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
    Manufacturer defined limits for improperly functioning loudspeakers of the hamilton c2 alarm system were exceeded.
  • Acción
    Hamilton Medical sent an Medical Device Safety Alert and Corrective Action letter dated September 27, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The corrective action does not require any action by the operator. In the case of an alarm situation as described in the letter, users should follow the instruction for use (Section 8 - responding to alarms in the operator manual) and have the ventilator serviced by an authorized service technician. An addendum to the Operators Manual as a result of the field correction was provided to customers with the Safety Alert Letter. Manufacture will develop and provision a test protocol for the service tech which test the proper functioning of the loudspeaker during the annual service inspection. We appreciate your support in this matter and sincerely regret any inconveniences that this action may cause you. We consider this action as necessary to ensure that our customers receive only safe and effective products with high quality. Further questions please call (775) 426-6331 Ext. 210

Device

Hamilton C2 Ventilator
  • Modelo / Serial
    Hamilton-C2; Serial numbers from 1000-7100.
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution: USA including Puerto Rico and the states of IL, MT, IN, ND, AZ, MT, KY, NC, OH, MA, MO, VA, CA, NV, TX, WA, NY, GA, SC,MN, WY, PA, ND, UT, NE, CO and MI.
  • Descripción del producto
    HAMILTON-C2 Ventilator: || Manufactured by Hamilton Medical AG || CH-7402 Bonaduz, Switzerland; || Imported and distributed by Hamilton Medical, Inc. Reno, NV 89502 || The HAMILTON C2 ventilator is intended to provide positive pressure ventilatory support to adults, pediatrics, infants and neonates depending on its configuration. Intended areas of use: In the intensive care ward or in the recovery room; During transfer of ventilated patients within the hospital.
  • Manufacturer
    Hamilton Medical, Inc.

Manufacturer

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