BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPRT SLEEP SURFACE

    MDR report key: 3747270 · Received April 12, 2014

    Report

    Report Number
    0001831750-2014-02881
    Event Type
    Malfunction
    Date Received
    April 12, 2014
    Date of Event
    March 19, 2014
    Report Date
    March 19, 2014
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    IKZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP SUBMITTED TO REPORT THE MATTRESS COVER WAS REPLACED.

    Additional Manufacturer Narrative · 1

    CONCLUSION: PARTS ON ORDER.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE MATTRESS COVER HAS A HOLE WITH 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 COVER HAS A HOLE WITH 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
    226030 XPRT SLEEP SURFACE BED, PATIENT ROTATION, POWERED IKZ STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1