BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTALCARE

    MDR report key: 2031694 · Received February 24, 2011

    Report

    Report Number
    1824206-2011-01082
    Event Type
    Malfunction
    Date Received
    February 24, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 1, 2011
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECHNICIAN FOUND THE LAL TOPPERS WERE AN OLDER STYLE WITH THE STITCHES AT THE HEAD END AND THE TICKING AROUND THE STITCHING IS TORN. AN ODOR WAS COMING FROM THE LAL TOPPER AND HE FOUND SIGNS OF SOMETHING THAT HAD ENTERED INTO THE LAL TOPPER AND DRIED. NEW TICKING'S ARE BEING SENT TO THE ACCOUNT TO REPAIR THE BEDS.

    Description of Event or Problem · 1

    THE ACCOUNT ALLEGED THAT THE TOP STITCHING ON THE LOW AIR LOSS (LAL) TOPPER IS TEARING. THE MATTRESSES ARE ALMOST THREE YEARS OLD.

    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