Events

Retiro De Equipo (Recall) de Device Recall Fabius MRI

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
    79773
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-1481-2018
  • Fecha de inicio del evento
    2018-03-01
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=163353
  • 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
    Gas-machine, anesthesia - Product Code BSZ
  • Causa
    The automatic ventilation may fail if the position detection of the motor is disturbed. if the ventilator cover is damaged, manual ventilation may also fail.
  • Acción
    On March 1, 2018, the recalling firm notified affected customers via an Urgent Medical Device Recall letter. The recalling firm stated that customers would receive replacement motors for potentially affected devices. Until the replacement occurred, customers were instructed to continue to operate their devices with the usual attention and make sure that a manual resuscitator for emergency ventilation is kept ready according to the instructions for use. Customers were also supplied with a reply card to indicate that they had received the notification. Customers with questions about the letter were directed to call Michael Kelhart between 8AM-4:30PM EST at 1-800-437-2437 (press 1 at the prompt, then 32349). Questions regarding the operation and/or servicing of the Draeger Fabius anesthesia machine were directed to DraegerService Technical Support between the hours of 8:00 AM  8:00 PM EST at 1-800-437-2437 (press 4 at the prompt then 4 again).

Device

Device Recall Fabius MRI
  • Modelo / Serial
    Serial no: ASKM-0020 ASKM-0011 ASKL-0005 ASKL-0007 ASKL-0010 ASKM-0031 ASKM-0032 ASKM-0023
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Nationwide Distribution to accounts in 21 states: AZ, CA, CO, ID, IL, KS, MA, MI, MS, NC, NY, OH, OK, PA, RI, TN, TX, UT, VA, WA, WI; and PR.
  • Descripción del producto
    Fabius MRI, anesthesia machine, catalog no. 8607300 || Product Usage: || The products are inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, N2O, and AIR supplied by a medical gas pipeline system or by externally mounted gas cylinders. Fabius series anesthesia machines are equipped with an electrically driven and electronically controlled ventilator and monitors for airway pressure (P), volume (V), and inspiratory oxygen concentration (FiO2). This device can also be used in MRI scanner rooms with magnets 1.5 tesla and 3 tesla at a fringe field strength of 40 mtesla or less.
  • 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