BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTALCARE

    MDR report key: 2260447 · Received August 19, 2011

    Report

    Report Number
    1824206-2011-04409
    Event Type
    Malfunction
    Date Received
    August 19, 2011
    Date of Event
    August 4, 2011
    Report Date
    August 4, 2011
    Manufacturer
    HILL-ROM INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECHNICIAN USED A MATTRESS REVITALIZATION KIT TO REPAIR THE BED.

    Description of Event or Problem · 1

    INFO REC'D INDICATES THE MATTRESS IS SUNKEN IN THE SEAT AND CHEST SECTION. THE TECHNICIAN FOUND THE MATTRESS FOAM AND TICKING WERE WORN AND THERE WAS FLUID INGRESS INTO THE FOAM.

    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 UNK