BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPRT MATTRESS W/O PENDANT

    MDR report key: 3911929 · Received July 3, 2014

    Report

    Report Number
    0001831750-2014-03130
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    June 9, 2014
    Report Date
    June 9, 2014
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    IKZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MATTRESS COVER WAS REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE MATTRESS HAD FLUID INTRUSION DUE TO A TORN BOTTOM 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
    390294 XPRT MATTRESS W/O PENDANT BED, PATIENT ROTATION, POWERED IKZ STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1