BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTALCARE

    MDR report key: 1954088 · Received December 16, 2010

    Report

    Report Number
    1824206-2010-11665
    Event Type
    Malfunction
    Date Received
    December 16, 2010
    Date of Event
    November 22, 2010
    Report Date
    November 22, 2010
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECHNICIAN REPLACED THE HYDRAULIC BLOCK TO REPAIR THE BED.

    Description of Event or Problem · 1

    INFO RECEIVED INDICATES THE BED HAD AN ISSUE WITH REVERSE TRENDELENBURG. THE TECHNICIAN REPAIRED THE BED BY REMOVING AND REPOSITIONING REVERSE TREND VALVE ON THE HYDRAULIC BLOCK, BUT AFTERWARDS THE FOOT HI/LOW WOULD NOT STAY UP AND WOULD DRIFT DOWN THEN NOT GO UP AT ALL.

    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