BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSITIONPRO WITH PENDANT

    MDR report key: 3934288 · Received July 15, 2014

    Report

    Report Number
    0001831750-2014-03160
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Date of Event
    June 27, 2014
    Report Date
    June 27, 2014
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FNM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PARTS SENT TO CUSTOMER TO PERFORM REPAIR.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE MATTRESS POWER CORD WAS FRAYED WITH EXPOSED WIRING. 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
    414006 POSITIONPRO WITH PENDANT MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE FNM STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1