BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTALCARE

    MDR report key: 5825429 · Received July 27, 2016

    Report

    Report Number
    5825429
    Event Type
    Malfunction
    Date Received
    July 27, 2016
    Date of Event
    May 6, 2016
    Report Date
    May 16, 2016
    Manufacturer
    HILL-ROM, INC.
    Product Code
    IOQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE PT WAS IN A HOSPITAL BED WHICH WOULD NOT MAINTAIN HEAD ELEVATION (I.E. PT'S HEAD-OF-BED (HOB) WAS RAISED TO A 30-DEGREE ANGLE BUT WITHIN A FEW MINUTES PATIENT WAS NOTED TO BE LYING FLAT). NOTE, THE BED WAS AT LOWEST LEVEL TO THE GROUND AS IT SHOULD HAVE BEEN TO MAINTAIN HOB ELEVATION AND STILL DID NOT WORK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479019 TOTALCARE BED, FLOTATION THERAPY, POWERED IOQ HILL-ROM, INC. P1900N

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR