Events

Rappel de Device Recall Maxi Move

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Arjo, Inc..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    50151
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0503-2009
  • Date de mise en oeuvre de l'événement
    2008-11-05
  • Date de publication de l'événement
    2008-12-16
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2010-01-05
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74835
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Non-AC Powered Patient Lift - Product Code FSA
  • Cause
    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.
  • Action
    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
  • Modèle / numéro de série
    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.
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution
  • Description du dispositif
    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.
  • Adresse du fabricant
    Arjo, Inc., 50 Gary Ave, Roselle IL 60172-1605
  • Source
    USFDA