BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTALCARE BED

    MDR report key: 2920856 · Received December 26, 2012

    Report

    Report Number
    1824206-2012-08510
    Event Type
    Malfunction
    Date Received
    December 26, 2012
    Date of Event
    December 6, 2012
    Report Date
    December 6, 2012
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECHNICIAN FOUND THE HEAD MATTRESS TO BE WORN ALLOWING FLUID INGRESS INTO THE MATTRESS. THE TECHNICIAN REPLACED THE PERCUSSION VIBRATION BLADDER, HEAD BLADDER AND THE TREATMENT REVITALIZATION KIT TO RESOLVE THE ISSUE.

    Description of Event or Problem · 1

    THE TECHNICIAN ALLEGED THERE WAS FLUID INGRESS INTO THE MATTRESS. NO PT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOTALCARE BED A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM, INC. 1900

    Patients

    Seq Age Sex Outcome Treatment
    1