BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIKING XL

    MDR report key: 4120622 · Received July 28, 2014

    Report

    Report Number
    8030916-2014-00065
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 1, 2014
    Manufacturer
    LIKO AB
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ROOT CAUSE WAS DETERMINED TO BE AN INSTALLATION ERROR. THE BOLTS WERE OVERTIGHTENED POINT CAUSING THE SECURING BRACKET TO BECOME DEFORMED/DAMAGED. A NEW ACCESSORY WAS PROVIDED TO THE CUSTOMER TO RESOLVE THE ISSUE. THIS ACCESSORY IS INSTALLED IN THE FIELD BY CUSTOMERS, FIELD TECHNICIANS AND DISTRIBUTORS VIA INSTRUCTION PROVIDED BY HILL-ROM.

    Description of Event or Problem · 1

    IT WAS REPORTED TO HILL-ROM THAT THE ARM REST ACCESSORY HAS BECOME DETACHED FROM A VIKING XL MOBILE LIFT. THERE WAS NO REPORTED PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439866 VIKING XL NON-AC POWERED PATIENT LIFT FSA LIKO AB 2040033

    Patients

    Seq Age Sex Outcome Treatment
    1