BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTALCARE

    MDR report key: 1960131 · Received December 17, 2010

    Report

    Report Number
    1824206-2010-11765
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Date of Event
    November 23, 2010
    Report Date
    November 23, 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 TECH FOUND THE FOOT WOULD NOT TRAVEL UP/DOWN REGULARLY BUT WOULD WHEN IN CALIBRATION MODE. HE REPLACED THE FOOT ARTICULATION POSITION SENSOR BUT THE PROBLEM STILL REMAINED. HE FOUND THAT THE POSITION SENSORS FOR THE HI/LOW FUNCTIONS WERE DISCONNECTED FROM THE POWER SUPPLY BOARD. AFTER RECONNECTION OF HI/LOW POSITION SENSOR, ALL OF THE BED FUNCTIONS WORKED.

    Description of Event or Problem · 1

    INFO RECEIVED INDICATES REVERSE TRENDELENBURG IS NOT WORKING WHEN THE BED IS FULLY RAISED.

    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