BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTALCARE

    MDR report key: 2212166 · Received July 8, 2011

    Report

    Report Number
    1824206-2011-03623
    Event Type
    Malfunction
    Date Received
    July 8, 2011
    Date of Event
    June 23, 2011
    Report Date
    June 23, 2011
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECHNICIAN REPLACED THE MANUAL TREND VALVE BUT THE ISSUE REMAINED. THE TECHNICIAN REPLACED THE HYDRAULIC MANIFOLD TO REPAIR THE BED.

    Description of Event or Problem · 1

    INFORMATION RECEIVED INDICATES WHILE PERFORMING PREVENTIVE MAINTENANCE ON THE BED, THE TECHNICIAN FOUND THE TRENDELENBURG FUNCTION WAS NOT WORKING.

    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