BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIG WHEEL STRETCHER, PRIME X

    MDR report key: 3240591 · Received July 22, 2013

    Report

    Report Number
    0001831750-2013-06534
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Date of Event
    June 26, 2013
    Report Date
    June 26, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS FOUND THAT THE STEER WOULD NOT REMAIN ENGAGED DUE TO A MISSING BOLT ON THE PATIENT RIGHT SIDE OF THE BIG WHEEL CARRIAGE. THE TECHNICIAN REPORTED THAT THE BRAKES COULD STILL BE ENGAGED. THIS IS NOT LIKELY TO HARM THE PATIENT AS THE STEER FEATURE IS A CUSTOMER PREFERENCE FEATURE. THE STRETCHER REMAINS MOBILE AND CAN STILL BE NAVIGATED WITHOUT USE OF THE STEER FEATURE. THIS ISSUE IS NOT LIKELY TO CAUSE OR CONTRIBUTE TO SERIOUS INJURY OR DEATH IF IT WAS TO REOCCUR.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE UNIT WAS POPPING OUT OF BRAKE DUE TO A MALFUNCTION PIVOT CARRIAGE BUSHING. 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 UNIT WAS POPPING OUT OF BRAKE DUE TO A MALFUNCTION PIVOT CARRIAGE BUSHING. 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
    341640 BIG WHEEL STRETCHER, PRIME X STRETCHER, WHEELED FPO STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1