BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIG WHL STRTCHR, PRIME X,PWRD

    MDR report key: 3221379 · Received July 11, 2013

    Report

    Report Number
    0001831750-2013-06262
    Event Type
    Malfunction
    Date Received
    July 11, 2013
    Date of Event
    June 11, 2013
    Report Date
    June 13, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL AND FUNCTIONAL INSPECTION WAS PERFORMED BY THE STRYKER FIELD SERVICE REPRESENTATIVE. IT WAS FOUND THAT THE ALLEGED ISSUE OF BRAKES NOT ENGAGING COULD NOT BE DUPLICATED AND THE BRAKES HAD NORMAL OPERATION. NO OTHER DEFECTS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE BRAKES WERE NOT ABLE TO ENGAGE. 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 BRAKES WERE NOT ABLE TO ENGAGE. 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
    319420 BIG WHL STRTCHR, PRIME X,PWRD STRETCHER, WHEELED FPO STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1