Events

Retiro De Equipo (Recall) de Device Recall Pulmonetic System Universal Cable Adaptor for use on LTV Series Ventilator, Model 950

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 Pulmonetic Systems, 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
    30514
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-0294-05
  • Fecha de inicio del evento
    2004-11-19
  • Fecha de publicación del evento
    2004-12-08
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2005-12-13
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=36028
  • 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
    Continuous, Ventilator, Home Use - Product Code NOU
  • Causa
    Reports have been received indicating that the universal cable adaptor, intended to correct an earlier class i recall of ltv series ventilators due to their inability to continue operating when external power source is switched to internal battery, is not functioning as intended and/or the cable is not securely attaching to the connection on the ventilator.
  • Acción
    Beginning November 19, 2004 consignees who received the Universal Cable Adaptors (UCA) as correction to the voluntary November 1, 2004 Class I Recall were notified by telephone to discontinue installation of adaptors in stock. A Universal Cable Adaptor Recall Notification will be distributed by Certified Mail on or about November 30, 2004 providing instruction to remove the UCA and instruct consignees to follow November 1, 2004 recall interim instructions. Additionally, all consignees will receive instructions (on December 7, 2004) on how to return any device affected by the November 1, 2004 Recall for a power board replacement at a Pulmonetic systems, Inc. authorized service center.

Device

Device Recall Pulmonetic System Universal Cable Adaptor for use on LTV Series Ventilator, Model...
  • Modelo / Serial
    all Universal Cable Adapters identified on outer packaging as part no. 17820-001 and distributed between 11/02/04 and 11/08/04.
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    throughout the United States and to countries such as Germany, Canada, United Kingdom, Australia and Japan
  • Descripción del producto
    Universal Cable Adaptor (Part #17765-001and labeled on outer package as part no. 17820-001) distributed for Field Installation on certain LTV Series Ventilator, Model 950 with either part # 10134 or 11511 power boards affected by the Pulmonetic Systems, Inc., November 1, 2004 Class I recall. (FDA Z-1485-04)
  • Manufacturer
    Pulmonetic Systems, Inc.

Manufacturer

Pulmonetic Systems, Inc.
  • Dirección del fabricante
    Pulmonetic Systems, Inc., 17400 Medina Rd Ste 100, Minneapolis MN 55447-1341
  • Source
    USFDA