BEUDAMED
    FDA Adverse Event Other Summary report: N

    TOTALCARE BED

    MDR report key: 2872377 · Received December 3, 2012

    Report

    Report Number
    1824206-2012-07848
    Event Type
    Other
    Date Received
    December 3, 2012
    Date of Event
    November 9, 2012
    Report Date
    November 9, 2012
    Manufacturer
    HILL-ROM IC.
    Product Code
    FNL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPLACED THE MATTRESS TO RESOLVE THE ALLEGED ISSUE OF FLUID INGRESS INTO THE MATTRESS. THE CAUSE OF THE INGRESS IS UNKNOWN.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED A "STENCH" COMING FROM THE MATTRESS. THE MATTRESS WAS OPENED AND THEY ALLEGEDLY FOUND FLUID INGRESS INSIDE THE MATTRESS. THEY STATED THAT THEY HAVE BEEN USING "QUATERNARY AMMONIA" TO CLEAN THE MATTRESS, AND THAT THE MATTRESS TICKING HAD NEVER BEEN OPENED UNTIL THE DISCOVERY OF FLUID INGRESS. THE BED WAS LOCATED ON THE FOURTH FLOOR ICU WHEN THE ALLEGED PROBLEM WAS FOUND. THEY ARE ALLEGING THAT THE PATIENT HAS CONTRACTED A BACTERIA FROM THE MATTRESS, BUT WOULD NOT TELL STATE WHAT KIND OF BACTERIA.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other