Events

Retiro De Equipo (Recall) de Device Recall Pulmonetic Systems

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 CareFusion 203, 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
    56201
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2205-2010
  • Fecha de inicio del evento
    2010-07-02
  • Fecha de publicación del evento
    2010-08-10
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-12-17
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92962
  • 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
    Carefusion is recalling the p/n 19189-001 patient circuit (spu w/o peep 15ft) because some of the circuit sense lines may have been reversed during the manufacturing process. if the sense lines have been reversed, immediately upon connection of the patient circuit to the ventilator and turning the ventilator on, the ventilator will begin to autocycle (with increased pressure delivered) with both.
  • Acción
    Customers were sent a CareFusion "Urgent Medical Device Recall Notification" dated July 2, 1010. The letter was addressed to Respiratory Care Manger. The letter described the product , problem and advised consignees to remove the affected product from inventory and promptly return it to CareFusion for replacement. Please contact CareFusion Technical Support at 800-754-1914, option 2, upon receipt of this notification to arrange for prompt return and replacement of any the patient circuits in your inventory.

Device

Device Recall Pulmonetic Systems
  • Modelo / Serial
    Y09D1922 Y09H0564 Y09H0565 Y09K0491 Y09K0492 Y09S1283 Y09S1284 Y10A1230
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution: AL, CA, FL, GA, HI, IL, IN, KS, MA,MI, MN, MT, NJ, NY, NC, OR, PA, RI, TN, TX, UT, VA, WA, and WI.
  • Descripción del producto
    Pulmonetic Systems P/N 19189-001 Patient Circuit SPU W/O PEEP 15 FT 5/Pkg. || These circuits are intended for use with the MR Conditional LTV 1200 System with the ventilator utilizing an external exhalation valve, as single patient use (SPU) only patient circuits for adult and pediatric patients. The LTV 1200 ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The ventilator is suitable for use in institutional, home and transport settings, and is applicable for adult and pediatric patients weighing at least 5 kg (11 lbs.), who require the following types of ventilatory support: -Positive Pressure Ventilation, delivered invasively (via ET tube) or non-invasively (via mask). -Assist/Control, SIMV, CPAP or NPPV modes of ventilation. -Breath types including Volume, Pressure Control and Pressure Support.
  • Manufacturer
    CareFusion 203, Inc.

Manufacturer

CareFusion 203, Inc.
  • Dirección del fabricante
    CareFusion 203, Inc., 17400 Medina Rd Ste 100, Minneapolis MN 55447-1341
  • Empresa matriz del fabricante (2017)
    Vyaire Holding Company
  • Source
    USFDA