Events

Retiro De Equipo (Recall) de MPM, CAM01 PAC 1

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 Integra LifeSciences Corp.

¿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
    60836
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0944-2012
  • Fecha de inicio del evento
    2011-10-20
  • Fecha de publicación del evento
    2012-02-03
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-06-18
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106616
  • 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
    Device, monitoring, intracranial pressure - Product Code GWM
  • Causa
    Some of the connector cables associated with integra's intracerebral pressure (icp) monitors may cause temporary interference with the icp waveform on the monitor display.
  • Acción
    Integra sent a Urgent Product Recall Notification letter dated October 20, 2011, via FedEx, email, and fax to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The customer was instructed to examine their inventory at your earliest convenience. If you have an effected PAC1 cable, please complete the attached Recall Acknowledgement Form and return it to Integra Customer Service per the instructions on the form. An Integra Sales Representative will contact you to assist in the return and replacement of new cables at no cost. In the meanwhile, you may continue to use the cables until you have been contacted and replacement product has been provided. Distortion of the ICP wave form can be stopped or prevented by keeping the PACI catheter receptacle out of human contact. Please contact Integra Customer Service at 1-800-654-2873.

Device

MPM, CAM01 PAC 1
  • Modelo / Serial
    MPM, CAMO1, PAC1 :  MEF1100103;MED1102303; MEB1101602; MEF1100203; MEC1100602;MED1101003; MED1102203; MEE1102003; MED1102103; MEC1102302; MEB1101402; MEE1101003; MEF1100703; MEE1101903; MEF1101103; MEB1100803; MEC1103002; MEE1100903; MED1101703; MED1101203; MEC1102902; MEB1101103; MEC1102002; MEB1101502; MED1102203; MEF1100603; MEE1101203; MEC1100102; MEE1101503; MEE1100703; MEF1100403; MED1101303; MED1101403; MEF1100303; MEC1100702; MED1101103; MEC1102402; MEC1101602; MEF1100903; MEE1101303; MED1102003; MEC1103302; MEE1101803; MEE1100803; MEF1100503; MEC1102502; MEC1101702; MEE1101403; MEC1103402; MEF1100803; MEC1102802; MEC1101802;MEF1101003; MEC1103102; MEC1101902; MEC1102102
  • Clasificación del producto
    Neurological Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-- USA (nationwide ) .
  • Descripción del producto
    Integra PAC1 Mod 2 Cables used with the Integra MPM, CAM01 Monitors
  • Manufacturer
    Integra LifeSciences Corp

Manufacturer

Integra LifeSciences Corp