BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SM204 M-SERIES W/BIG WHEEL

    MDR report key: 3102849 · Received May 9, 2013

    Report

    Report Number
    0001831750-2013-04218
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    April 11, 2013
    Report Date
    April 11, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE SIDE RAILS COULD NOT LATCH UP DUE TO BROKEN TOP RAIL PIVOTS AT THE LATCHING SPINDLE AND THE BRAKES WOULD NOT ENGAGE/HOLD DUE TO WORN BRAKE RINGS. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Description of Event or Problem · 1

    THIS IS A DUPLICATE OF MFR REPORT # 0001831750-2013-04215. THE SERIAL NUMBER (B)(4) AND CATALOG NUMBER 1015000000 REPORTED FOR THIS COMPLAINT WERE ACCIDENTALLY SUBMITTED INTO THE COMPLAINT HANDLING SYSTEM TWICE FOR THE EXACT SAME COMPLAINT INSTANCE. PLEASE REFER TO MFR REPORT # 0001831750-2013-04215 FOR FULL REPORTING OF SERIAL NUMBER (B)(4) AND CATALOG NUMBER 1015000000 FOR THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204633 SM204 M-SERIES W/BIG WHEEL STRETCHER, WHEELED FPO STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1