BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPRT MATTRESS W/O PENDANT

    MDR report key: 3730276 · Received April 7, 2014

    Report

    Report Number
    0001831750-2014-02859
    Event Type
    Malfunction
    Date Received
    April 7, 2014
    Date of Event
    March 11, 2014
    Report Date
    March 11, 2014
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    IKZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: REPLACED COVER.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE TOP COVER HAD MULTIPLE RIPS AND TEARS 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
    206290 XPRT MATTRESS W/O PENDANT BED, PATIENT ROTATION, POWERED IKZ STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1