Events

Retiro De Equipo (Recall) de Rotoprone Therapy System

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 ArjoHuntleigh 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
    67248
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0926-2014
  • Fecha de inicio del evento
    2013-09-11
  • Fecha de publicación del evento
    2014-02-04
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-01-08
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125084
  • 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
    Bed, patient rotation, powered - Product Code IKZ
  • Causa
    The lock pin can become stuck in the "in" position during the manual rotation, resulting in the inability to prone a patient.
  • Acción
    ArjoHuntleigh Inc. sent a Technical Bulletin package to all affected service centers and an Urgent Field Safety Notice package to all affected customers. For rental units, a training plan was established for employees. For sold units, the notice contain a revised user manual and label explaining what to do if the lock pin becomes stuck in the "in" position. Customers that purchased the affected product were required to complete and return a Customer Response form to ArjoHuntleigh to confirm receipt and understanding of the field safety notice, and that the required actions were completed. For questions call 630-785-4885.

Device

Rotoprone Therapy System
  • Modelo / Serial
    Model #209500
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Nationwide and Middle East
  • Descripción del producto
    The Rotoprone therapy System is an advanced patient care system for the treatment and prevention of pulmonary complications. The Rotoprone Therapy System provides up to 62 degrees in both prone and supine positions as well as Trendelenburg/Reverse Trendelenburg positioning. || Product Usage: Use of the Rotoprone Therapy System is indicated for patients with severe acute respiratory distress syndrome (ARDS). These are critical patients who are at higher risk of cardiac arrest and mortality. Placing a patient in the prone position may reopen collapsed airways and thus improve pulmonary gas exchange and respiratory mechanics.
  • Manufacturer
    ArjoHuntleigh Inc.

Manufacturer

ArjoHuntleigh Inc.
  • Dirección del fabricante
    ArjoHuntleigh Inc., 4958 Stout Dr, San Antonio TX 78219-4334
  • Empresa matriz del fabricante (2017)
    Getinge AB
  • Source
    USFDA