BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIME BIG WHEEL STRETCHER,30"

    MDR report key: 3190645 · Received June 26, 2013

    Report

    Report Number
    0001831750-2013-05820
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    May 30, 2013
    Report Date
    May 30, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE SIDE RAIL WAS DIFFICULT TO LATCH AND COULD RESULT IN A FALSE SENSE THAT THE SIDE RAIL WAS LATCHED DUE TO A DAMAGED LATCH HANDLE. 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
    291564 PRIME BIG WHEEL STRETCHER,30" STRETCHER, WHEELED FPO STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1