BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPRT MATTRESS W/O PENDANT

    MDR report key: 2971658 · Received February 21, 2013

    Report

    Report Number
    0001831750-2013-01391
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    January 25, 2013
    Report Date
    January 28, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    IKZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP SUBMITTED WITH EVALUATION RESULTS WHICH DETERMINED THE MATTRESS HAD AN UNPLEASANT ODOR. PINK DISCOLORATION FOUND ON TOP COVER AT ZIPPER SEAM BUT COULD NOT BE CONFIRMED TO BE FLUID INGRESS. MATTRESS WAS REPLACED

    Additional Manufacturer Narrative · 1

    RESULTS: LIQUID INGRESS ALLEGED. CONCLUSION: NO CONCLUSION UNTIL PRODUCT IS EVALUATED. AT THAT TIME, IF APPROPRIATE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SALES REPRESENTATIVE THAT THE XPERT MATTRESS POTENTIALLY HAD LIQUID INGRESS ALONG THE ZIPPER.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SALES REPRESENTATIVE THAT THE XPERT MATTRESS POTENTIALLY HAD LIQUID INGRESS ALONG THE ZIPPER. 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
    76605 XPRT MATTRESS W/O PENDANT BED, PATIENT ROTATION, POWERED IKZ STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1