BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTALCARE

    MDR report key: 1120093 · Received August 15, 2008

    Report

    Report Number
    1824206-2008-03106
    Event Type
    Malfunction
    Date Received
    August 15, 2008
    Date of Event
    July 30, 2008
    Report Date
    July 30, 2008
    Manufacturer
    HILL-ROM RITTER
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ACCOUNT ALLEGED THAT FLUID INGRESSED INTO THE MATTRESS THROUGH THE ZIPPER. NO PATIENT WAS IMPACTED BY THE FAILURE. ACCOUNT DID NOT REPAIR FLUID INGRESS ISSUE. ACCOUNT PUT BED BACK INTO SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOTALCARE AC POWERED HOSPITAL BED FNL HILL-ROM RITTER 1900 P1900D003408

    Patients

    Seq Age Sex Outcome Treatment
    1