BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTALCARE BED

    MDR report key: 2934916 · Received December 21, 2012

    Report

    Report Number
    1824206-2012-08489
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    December 5, 2012
    Report Date
    December 5, 2012
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE HILL-ROM TECHNICIAN FOUND A SMASHED SIDERAIL CABLE AND CORROSION ON THE CIRCUIT BOARD DUE TO SMALL FRACTION OF FLUIDS ENTERING INTO THE SIDERAIL. THE SIDERAIL COVER DID NOT HAVE THE SEAL GASKET. THE TECHNICIAN REPLACED THE CABLE AND CIRCUIT BOARD TO RESOLVE THE ISSUE.

    Description of Event or Problem · 1

    INFORMATION RECEIVED INDICATED THE LEFT USER CONTROL MODULE CONTROLS ARE OPERATING INTERMITTENTLY WHEN LOWERING THE SIDERAIL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1