BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTALCARE

    MDR report key: 1112731 · Received August 11, 2008

    Report

    Report Number
    1824206-2008-03034
    Event Type
    Malfunction
    Date Received
    August 11, 2008
    Date of Event
    July 21, 2008
    Report Date
    July 21, 2008
    Manufacturer
    HILL-ROM RITTER
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN 2008, RER STATED THE BED FUNCTIONS DO NOT WORK, NO INJURY OR INCIDENT REPORTED. EIGHT DAYS LATER, SUM - REP RETURNED CALL ADVISING THE PT PENDANT WAS DAMAGED AND CAUSING OTHER CONTROLS NOT TO WORK. HE DISCONNECTED THE PENDANT AND NOW THE BED FUNCTIONS AND IS BACK IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOTALCARE AC POWERED HOSPITAL BED FNL HILL-ROM RITTER 1900 P1900

    Patients

    Seq Age Sex Outcome Treatment
    1