Events

Retiro De Equipo (Recall) de Device Recall Maxi Move

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 Arjo, 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
    50151
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0503-2009
  • Fecha de inicio del evento
    2008-11-05
  • Fecha de publicación del evento
    2008-12-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-01-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74835
  • 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
    Non-AC Powered Patient Lift - Product Code FSA
  • Causa
    The battery pack nda0200-20, lot 070826d, sold with the maxi move patient lift or as replacement parts, has a defective connector that could lead to the inability of the battery pack to recharge and/or short circuit, resulting in smoke emission.
  • Acción
    Arjo sent the Urgent Device Recall Customer Notification dated 11/5/08 and Field Safety Notice (FSN) dated 10/31/08 to all affected Maxi Move customers on 11/5/08. The accounts were informed of the problem with the connector of the battery pack NDA0200-20, lot 070826D, sold with the Maxi Move patient lift (model numbers starting with KMC)or as replacement parts. They instructed the accounts to discontinue use of the battery pack if it does not recharge or has an intermittent electrical contact. The accounts were requested to complete and return to Arjo Inc., the enclosed customer response form indicating that they have received the notification package. The accounts will be contacted by an Arjo representative within a week to arrange the replacement of the battery pack and corresponding connectors (male part/plug) on the lift and battery charger.

Device

Device Recall Maxi Move
  • Modelo / Serial
    lot number 070826D; This battery pack was solely supplied with Maxi Move floor lift model numbers starting with KMCxxx or sold separately as replacement parts.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    Maxi Move, Model NDA0200-20 Batteries Pack; BHM Medical Inc., 2001 Tanguay, Magog, QC, Canada J1X 5Y5 || The equipment is intended to be used in hospitals, nursing homes, or other health care facilities by trained caregivers for the transfer of patients.
  • Manufacturer
    Arjo, Inc.

Manufacturer

Arjo, Inc.
  • Dirección del fabricante
    Arjo, Inc., 50 Gary Ave, Roselle IL 60172-1605
  • Source
    USFDA