BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTALCARE

    MDR report key: 1082377 · Received July 25, 2008

    Report

    Report Number
    1824206-2008-02884
    Event Type
    Malfunction
    Date Received
    July 25, 2008
    Date of Event
    April 7, 2008
    Report Date
    May 13, 2008
    Manufacturer
    HILL-ROM RITTER
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN 2008, - REP, THERAPY SALES, STATED THAT THE OWNER OF THIS TOTALCARE BED HAS ALLEGED THAT HE DEVELOPED A STAGE 3 BED SORE. THE BED AND MATTRESS ARE 7 YEARS OLD. THE PATIENT ALLEGED TO REP VIA PHONE CALLS, THAT THE MATTRESS IS WORN OUT AND NEEDS TO BE REPLACED. REP STATED THAT SHE SUGGESTED, BASED ON WHAT THE PATIENT HAS ALLEGED, THAT THE PATIENT SHOULD BE ON A DIFFERENT SURFACE. PER THE TSR, AT THE TIME OF THE ALLEGED INCIDENT THERE WAS NO PRODUCT MALFUNCTION, JUST TYPICAL WEAR OF THE 7 YEAR OLD MATTRESS. PER THE PATIENT, ALLEGEDLY HE HAS HAD VARIOUS PRESSURE SORES OVER A 2 YEAR PERIOD. AT THIS TIME, THE CUSTOMER/PATIENT HAS DECLINED TO HAVE THE WORN MATTRESS COMPONENTS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOTALCARE AC POWERED HOSPITAL BED FNL HILL-ROM RITTER 1900 P1900D003509

    Patients

    Seq Age Sex Outcome Treatment
    1