BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTALCARE

    MDR report key: 1960098 · Received December 17, 2010

    Report

    Report Number
    1824206-2010-11726
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Date of Event
    December 7, 2010
    Report Date
    December 7, 2010
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TECH FOUND A HOLE IN THE MATTRESS TICKING, WITH FLUID STAINS ON INSIDE OF TICKING AND ON FIRE BARRIER. REPLACED TICKING AND FIRE BARRIER TO CORRECT THIS ISSUE.

    Description of Event or Problem · 1

    INFO REC'D ALLEGED THAT THERE WAS A HOLE IN THE MATTRESS TICKING. FLUID STAINS ON INSIDE OF TICKING AND ON FIRE BARRIER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOTALCARE AC POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM, INC. P1900BF4929

    Patients

    Seq Age Sex Outcome Treatment
    1