BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPRT MATTRESS WITH PENDANT

    MDR report key: 3817388 · Received May 19, 2014

    Report

    Report Number
    0001831750-2014-02988
    Event Type
    Malfunction
    Date Received
    May 19, 2014
    Date of Event
    April 30, 2014
    Report Date
    April 30, 2014
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    IKZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE FOAM CRIB ASSEMBLY WAS DISCOLORED AND HAD FLUID INTRUSION. 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
    297569 XPRT MATTRESS WITH PENDANT BED, PATIENT ROTATION, POWERED IKZ STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1