BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTALCARE

    MDR report key: 1821808 · Received August 26, 2010

    Report

    Report Number
    1824206-2010-09600
    Event Type
    Malfunction
    Date Received
    August 26, 2010
    Date of Event
    July 27, 2010
    Report Date
    July 27, 2010
    Manufacturer
    HILL-ROM INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACCOUNT CHANGED THE GCI BUT THIS DID NOT CHANGE THE RESPONSE OF THE BED. THE ACCOUNT REPLACED THE RIGHT USER CONTROL MODULE AND CABLE TO THE WEIGH FRAME JUNCTION BOARD BUT THE ISSUE REMAINED. AFTER REPLACING THE POWER CONTROL MODULE, THE SPEED OF THE GCI SPEED IMPROVED, BUT THE SCALE ERROR CODES REMAINED. AFTER CHANGING THE SCALE BOARD AND PERFORMING A SCALE CALIBRATION AND BED WORKED PROPERLY.

    Description of Event or Problem · 1

    THE ACCOUNT ALLEGED FLUID MAY HAVE GOTTEN INTO THE GCI. HE COULD SEE WHAT LOOKED LIKE RESIDUE FROM FLUID DRIED ON THE PRINTED CIRCUIT BOARD IN THE GCI MODULE AND SAID THE GCI SEAMED SLOW TO RESPOND AND HE GOT ERROR 50-23 AND 50-30.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOTALCARE AC POWERED HOSPITAL BED FNL HILL-ROM INC. 1900

    Patients

    Seq Age Sex Outcome Treatment
    1