Events

Recall of MinervaCombi Patient Lift

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medibo N.V..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    29662
  • Event Risk Class
    Class 1
  • Event Number
    Z-1381-04
  • Event Initiated Date
    2004-08-04
  • Event Date Posted
    2004-08-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-12-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=34396
  • Notes / Alerts
    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.
  • Extra notes in the data
    Lift, Patient, Non-Ac-Powered - Product Code FSA
  • Reason
    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

MinervaCombi Patient Lift
  • Model / Serial
    Model ML-30: serial numbers MPBC98022M654, MPBC98022M655, MPBC98022M678, MPBC98062M717, MPBC98062M718, MPBC98062M719, MPBC98062M720, MPBC98062M721, MPCV99102M914, MPCV99102M915, MPCV99102M916, MPCV00012M987, MPCV00072M1073, MPCV00082M1095, MPCV00082M1101
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    California, Florida, Louisiana, Massachusetts, New Hampshire, New Jersey, New York, Ohio, Oregon and Pennsylvania.
  • Product Description
    Minerva-Combi Patient Lift, model ML-30; this lift comes with interchangable passive and active lifting units; 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.
  • Manufacturer Address
    Medibo N.V., Heikant 5, Hanmont, Achel Belgium
  • Source
    USFDA