BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTE

    MDR report key: 3030253 · Received March 28, 2013

    Report

    Report Number
    9681684-2013-00020
    Event Type
    Malfunction
    Date Received
    March 28, 2013
    Date of Event
    February 28, 2013
    Report Date
    February 28, 2013
    Manufacturer
    ARJOHUNTLEIGH MAGOG INC.
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER EXEMPTION E2012068 BY THE MANUFACTURER ARJOHUNTLEIGH (B)(4) ON BEHALF OF THE IMPORTER (B)(4). THE DEVICE WAS INSPECTED ON-SITE BY A REPRESENTATIVE OF THE MANUFACTURER'S SALES AND SERVICE UNIT SUBSIDIARY DIVISION, NOT A DIRECT EMPLOYEE OF THE MANUFACTURER. ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE MANUFACTURER'S INVESTIGATION.

    Description of Event or Problem · 1

    THE CARRY STRAP BROKE DURING TRANSFER OVER A BED AND THE CAREGIVER HAD THE REFLEX TO PUSH THE RESIDENT IN THE BED. NO MAJOR INJURIES HAPPENED, MINOR SCRATCH AND BRUISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127385 LIBERTE MANUFACTURED CEILING FIXED CASSETTES FSA ARJOHUNTLEIGH MAGOG INC. LB-750

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR