BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTALCARE BED

    MDR report key: 2910546 · Received December 3, 2012

    Report

    Report Number
    1824206-2012-07855
    Event Type
    Malfunction
    Date Received
    December 3, 2012
    Date of Event
    November 9, 2012
    Report Date
    November 9, 2012
    Manufacturer
    HILL-ROM INC.
    Product Code
    FNL
    Product Problem
    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 IN THE MATTRESS. THE CAUSE OF THE PROBLEM IS UNKNOWN.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED A "STENCH" COMING FROM THE MATTRESS. THE MATTRESS WAS OPENED AND ALLEGEDLY FOUND FLUID INGRESS. 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 4TH FLOOR ICU WHEN THE ALLEGED PROBLEM WAS FOUND.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1