BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPRT MATTRESS W/O PENDANT

    MDR report key: 3817446 · Received May 19, 2014

    Report

    Report Number
    0001831750-2014-02986
    Event Type
    Malfunction
    Date Received
    May 19, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 5, 2014
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    IKZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUPPLEMENTAL SUBMITTED TO INDICATE THAT THE MATTRESS TOP COVER, BOTTOM COVER AND AIR BLADDER WERE SEALED IN DECONTAMINATION BAGS. THE TECHNICIAN COULD NOT FURTHER EVALUATE THE UNIT.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE MATTRESS HAD FLUID INTRUSION. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE MATTRESS 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
    295335 XPRT MATTRESS W/O PENDANT BED, PATIENT ROTATION, POWERED IKZ STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1