Events

Retiro De Equipo (Recall) de Device Recall Pneupac VR1

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 Smiths Medical PM, 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
    37968
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0991-2007
  • Fecha de inicio del evento
    2007-05-16
  • Fecha de publicación del evento
    2007-07-04
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-10-10
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=52551
  • 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 resuscitator - Product Code BTL
  • Causa
    Smiths medical is conducting a recall of 93 pneupac vr1 emergency & transport ventilators following the identification of a problem which may exist with the demand valve that could cause the ventilator to stop cycling & to deliver continuous flow output to the patient.
  • Acción
    Distriblutors and end users were contacted by phone (May 10 - May 24, 2007) and end users were additionally sent a Safety Action Bulletin May 21, 2007. The Bulletin was used as a script.

Device

Device Recall Pneupac VR1
  • Modelo / Serial
    serial number: 06-12-223, 06-12-225, 06-12-226, 06-12-227, 06-12-228, 06-12-247, 06-12-248, 06-12-249, 06-12-250, 06-12-251, 06-12-252, 06-12-253, 06-12-254, 06-12-255,   07-01-159, 0701-160, 07-01-161, 07-01-162, 07-01-163, 07-01-164, 07-01-165, 07-01-166, 07-01-167, 07-01-169, 07-01-170, 07-01-171, 07-01-187, 07-01-188, 07-01-189, 07-01-190, 07-01-191, 07-01-194, 07-01-195, 07-01-196, 07-01-197, 07-01-198, 07-01-199, 07-01-217, 07-01-218, 07-01-219, 07-01-220, 07-01-221, 07-01-222, 07-01-223, 07-01-224, 07-01-225, 07-01-226, 07-01-227, 07-01-228, 07-01-229, 07-01-230, 07-01-231, 07-01-232, 07-01-233, 07-01-234, 07-01-250, 07-01-251, 07-01-252, 07-01-253, 07-01-254, 07-01-255, 07-01-256, 07-01-257, 07-01-258, 07-01269, 07-01-207, 07-01-271, 07-01-272, 07-01-273, 07-01-274, 07-01-275, 07-01-276, 07-01-277, 07-01-421, 07-01-422, 07-01-423, 07-01-424, 07-01-428, 07-01-430, 07-01-431, 07-01-426, 07-01-427, 07-02-321, 07-02-324, 07-02-325, 07-02-326, 07-02-350, 07-02-351, 07-02-352, 07-02-358, 07-04-126,   07-01-200, 07-02-269,
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide.
  • Descripción del producto
    Pneupac VR1 Standard and VR1 Responder is a hand held portable, time cycled, gas powered, flow generator ventilatory resuscitators that are intended for emergency resuscitation by medical personnel, paramedics and ambulance technicians inside and outside hospital and for ventilation by medical personnel inside and outside hospital in emergency situations and for intra- and inter- hospital transport.
  • Manufacturer
    Smiths Medical PM, Inc.

Manufacturer

Smiths Medical PM, Inc.
  • Dirección del fabricante
    Smiths Medical PM, Inc., N7w22025 Johnson Dr, Waukesha WI 53186-1856
  • Source
    USFDA