BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REM 2000 35X80 DARTEX NO FB

    MDR report key: 2943704 · Received February 5, 2013

    Report

    Report Number
    0001831750-2013-00731
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Date of Event
    December 17, 2012
    Report Date
    January 11, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    IKY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ISSUE WAS RESOLVED FOR THE CUSTOMER BY PROVIDING REPLACEMENT MATTRESSES UNDER CUSTOMER ACCOMMODATION AS THE MATTRESSES COULD NOT BE FULLY EVALUATED DUE TO THE PRESENCE OF A LARGE EXTENT OF FLUID INGRESS.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT THERE WAS FLUID INGRESS TO THE MATTRESS.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT THERE WAS FLUID INGRESS TO THE MATTRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48676 REM 2000 35X80 DARTEX NO FB MATTRESS, FLOTATION THERAPY, NON-POWERED IKY STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1