BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTALCARE

    MDR report key: 2110495 · Received April 25, 2011

    Report

    Report Number
    1824206-2011-02330
    Event Type
    Malfunction
    Date Received
    April 25, 2011
    Date of Event
    March 29, 2011
    Report Date
    March 29, 2011
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TECHNICAL SUPPORT INSTRUCTED THE ACCOUNT TO ADJUST THE BRAKE ON THE CASTERS, AND IF THAT DID NOT CORRECT THE ISSUE TO REPLACE THE CASTERS. THE ACCOUNT HAS NOT RETURNED HILL-ROM'S ATTEMPTS TO DETERMINE THE RESOLUTION OF THE ALLEGED MALFUNCTION.

    Description of Event or Problem · 1

    THE ACCOUNT ALLEGED WHEN THE BRAKES ARE SET THE CASTER WILL STILL MOVE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1