BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPRT SLEEP SURFACE

    MDR report key: 3151505 · Received June 7, 2013

    Report

    Report Number
    0001831750-2013-05153
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    May 15, 2013
    Report Date
    May 15, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    IKZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY REPAIR WORK ORDER THAT THE MATTRESS HAD FLUID INGRESS DUE TO HOLES IN MATTRESS COVER. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253370 XPRT SLEEP SURFACE XPRT SLEEP SURFACE IKZ STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1