BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXI TWIN

    MDR report key: 2501466 · Received March 20, 2012

    Report

    Report Number
    9611530-2012-00040
    Event Type
    Malfunction
    Date Received
    March 20, 2012
    Report Date
    February 20, 2012
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    FNG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER EXEMPTION (B)(4) BY ARJOHUNTLEIGH (B)(4) ON BEHALF OF THE MANUFACTURER ARJO (B)(4). ADDITIONAL INFO WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE MANUFACTURER'S INVESTIGATION.

    Description of Event or Problem · 1

    LOOP SLING (MODEL # MLA4060-L) BEING USED WITH A MAXI TWIN LIFT CAME UNDONE SOMETIME DURING ITS WARRANTY PERIOD (DELIVERED TO THE FACILITY IN DECEMBER 2010). IT WAS REPORTED BY THE FACILITY THAT THERE WAS NO INCIDENT AND THAT THE SLING IS NOT CURRENTLY IN USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXI TWIN PASSIVE FLOOR LIFT FNG ARJO HOSPITAL EQUIPMENT AB

    Patients

    Seq Age Sex Outcome Treatment
    1 Other