BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTALCARE BARIATRIC PLUS

    MDR report key: 2823522 · Received October 8, 2012

    Report

    Report Number
    1824206-2012-06236
    Event Type
    Malfunction
    Date Received
    October 8, 2012
    Date of Event
    September 19, 2012
    Report Date
    September 19, 2012
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HILL-ROM TECHNICIAN FOUND THAT THE GROUND PIN WAS LOOSE ON THE POWER CORD. HE REPLACED THE POWER CORD AND THE BED FUNCTIONED TO DESIGN SPECIFICATIONS.

    Description of Event or Problem · 1

    INFO RECEIVED INDICATED THE BED FAILED A GROUND IMPEDANCE TEST WHILE PERFORMING SAFETY TESTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1