BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIME ZOOM STRETCHER, ELECTRIC

    MDR report key: 2925496 · Received January 22, 2013

    Report

    Report Number
    0001831750-2013-00268
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    January 2, 2013
    Report Date
    January 2, 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 PREVIOUSLY REPORTED THAT THE BRAKES COULD NOT BE ENGAGED AS A RESULT OF BROKEN PEDALS. HOWEVER, UPON COMPLETION OF THE INVESTIGATION IT WAS DETERMINED THAT THAT THE JACK PEDAL WAS DAMAGED. THIS IS NOT LIKELY TO RESULT IN SERIOUS INJURY OR DEATH BECAUSE THE JACK COULD STILL BE RAISED AND LOWERED USING AN ALTERNATIVE PEDAL. ADDITIONALLY, NO EXPOSED SHARP EDGES WERE REPORTED AS A RESULT OF THE DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT THE BRAKES COULD NOT BE ENGAGED DUE TO BROKEN BRAKE PEDALS.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT THE JACK PEDAL WAS DAMAGED. HOWEVER, THE JACK COULD STILL BE RAISED AND LOWERED USING AN ALTERNATIVE PEDAL. ADDITIONALLY, NO EXPOSED SHARP EDGES WERE REPORTED AS A RESULT OF THE DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30001 PRIME ZOOM STRETCHER, ELECTRIC STRETCHER, WHEELED FPO STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1