Events

Rappel de Minerva Patient Lift

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 Medibo N.V..

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
    29662
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-1381-04
  • Date de mise en oeuvre de l'événement
    2004-08-04
  • Date de publication de l'événement
    2004-08-26
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2004-12-13
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=34303
  • 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
    Lift, Patient, Non-Ac-Powered - Product Code FSA
  • Cause
    The hanger bar may detach from the jib yoke, the m8 bolt in the foot pedal assembly may come loose, and some units may have faulty actuator brackets on the mast assembly, resulting in the patient lift becoming unstable and allowing the patient to fall.
  • Action
    Customer Advisory Notice (MB/0407/CAN-001) letters dated 8/6/04 were sent by FedEx Ground Service on 8/4/04 to the end users, informing them of the possibility of the hanger bar assembly to detach from the jib due wear of the pivot assembly within the yoke. They were also advised that the bolt in the foot pedal assembly could come loose, rendering the lift unstable, and that some of the lifts may have faulty actuator brackets on the mast assembly which could result in the collapse of the hoist. The users were requested to inspect their lifts or take them out of service pending service by an authorized service engineer. The users were requested to complete customer response form indicating the model numbers and serial numbers of the lifts at the facility, both in use and out of service, and fax the form back to the Minerva Recall Department at 1-888-594-2756 within 5 days. Within two weeks an authorized service engineer will contact each facility to schedule an appointment to service the lifts at Medibo''s expense. Any questions were directed to the Minerva Recall Department, at 1-888-402-6448.

Device

Minerva Patient Lift
  • Modèle / numéro de série
    Model ML-20: serial numbers 952056, 952057, 952112, 952113, 952114, 952115, 952116, 952117, 962118, 952119, 952120, 952121, 962214, 962215, 962216, 962217, 962218, 962235, 962236, 962238, 962239, 962240, 962241, MPBX 97052M563, MPBX97052M564, MPBX97052M565, MPBX97052M566, MPBX97052M567, MPBX97052M568, MPBX97052M569, MPBX97052M570, MPBX97052M571, MPBX97052M572, MPBX97052M573, MPBX97052M574, MPBX97052M575, MPBX97052M576, MPBX97052M577, MPBX97052M578, MPBX97052M579, MPBX98022M649, MPBX98022M650, MPBX98022M651, MPBX98022M652, MPBX98022M653, MPBX98022M676, MPBX98022M677, MPBV00032M1013, MPBV00072M1074,
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    California, Florida, Louisiana, Massachusetts, New Hampshire, New Jersey, New York, Ohio, Oregon and Pennsylvania.
  • Description du dispositif
    Minerva Patient Lift, model ML-20; this lift has a passive lifting unit; Manufactured by Medibo-Technics, Hasseltsebaan 24, 3940 Hechtel-Eksel, Belgium and distributed by MasterCare Patient Equipment, Inc., Hwy 61 West Industrial Park, Columbus, NE 68601
  • Manufacturer
    Medibo N.V.

Manufacturer

Medibo N.V.
  • Adresse du fabricant
    Medibo N.V., Heikant 5, Hanmont, Achel Belgium
  • Source
    USFDA