BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTALCARE BARIATRIC PLUS BED

    MDR report key: 2974471 · Received January 28, 2013

    Report

    Report Number
    1824206-2013-00718
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Date of Event
    January 3, 2013
    Report Date
    January 3, 2013
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECH FOUND THE HEAD HI-LOW VALVE STICKING AND NOT FULLY CLOSING AFTER ACTIVATION. THE TECH REMOVED AND CLEANED THE HEAD HI-LOW VALVE SEAT ASSEMBLY TO RESOLVE THE ISSUE.

    Description of Event or Problem · 1

    THE TECH ALLEGED THE HEAD HI-LO IS DRIFTING DOWN SLOWLY WHEN THE BED IS LEFT IN THE RAISED POSITION. NO PT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38495 TOTALCARE BARIATRIC PLUS BED A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM, INC. 1840

    Patients

    Seq Age Sex Outcome Treatment
    1