BEUDAMED
    FDA Recall Terminated

    Maxi Move Patient Lift with Lock & Load System (Combi Hanger); Manufactured by Arjo Hospital Equipment AB, Eslov, Sweden; Models KMBB4CLU2FUS, KMBB4MLU2FUS, KMBB4MSU2FUS, KMBB4NLX2FUS, KMBB4NSX2FUS, KMBB4OLU2FUS, KMBB4OSU2FUS, KMBB4PLX2FUS, KMBB4PSX2FUS, KMBB4QLU2FUS, and KMBB4RLX2FUS. The lifter is intended to be used under the direct supervision of trained personnel for the transfer of residents from one location to another.

    Recall: Z-2470-2008 · Initiated September 8, 2008

    Recall

    Recall Number
    Z-2470-2008
    Event Number
    49391
    Firm
    Arjo, Inc.
    FEI Number
    1419652
    Product Code
    FSA
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    September 8, 2008
    Posted
    September 30, 2008
    Terminated
    January 7, 2011
    Address
    50 Gary Ave, Roselle, IL, 60172-1605

    Description

    Maxi Move Patient Lift with Lock & Load System (Combi Hanger); Manufactured by Arjo Hospital Equipment AB, Eslov, Sweden; Models KMBB4CLU2FUS, KMBB4MLU2FUS, KMBB4MSU2FUS, KMBB4NLX2FUS, KMBB4NSX2FUS, KMBB4OLU2FUS, KMBB4OSU2FUS, KMBB4PLX2FUS, KMBB4PSX2FUS, KMBB4QLU2FUS, and KMBB4RLX2FUS. The lifter is intended to be used under the direct supervision of trained personnel for the transfer of residents from one location to another.

    Reason

    There is the potential for unintended dislocation of the Lock and Load hanger assembly (Combi Hanger) from the t-bar attached to the lifter jib of the Maxi Move patient lift.

    Action

    Arjo sent the Field Safety Notice (FSN) dated 8/11/08 to all Maxi Move with Lock & Load system (Combi Hanger) customers on 9/8/08. The accounts were informed of the problem unintended dislocation of the hanger and possible detachment during patient transfer. The notice provided details, including serial number ranges, to identify the affected patient lifts affected, and instructed the accounts to re-train caregivers on how to ensure the hanger is properly attached to the T-bar before and during the initial phase of all lifting operations. Included with the FSN was a package containing a repair/replacement kit for the bushings in the T-bar with instructions, and updated copies of the Operating and Product Care instructions as well as a Preventative Maintenance Schedule manuals. The accounts were requested to complete and return to Arjo Inc. the enclosed customer response form indicating that they have received the notification package, that they installed the bushings kits in their affected Maxi Moves, or if they would like an Arjo Service Technician to perform the installation. Those locations needing a T-bar replacement will be contacted by an Arjo representative within 2 months to arrange a replacement of the T-bars.

    Distribution

    Nationwide Distribution

    Quantity

    4,400 patient lifts