BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SM104 MSERIES W5TH WHLOBS3/07

    MDR report key: 3102920 · Received May 9, 2013

    Report

    Report Number
    0001831750-2013-04229
    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

    THIS IS A DUPLICATE OF MFR REPORT # 0001831750-2013-04219. THE SERIAL NUMBER (B)(4) AND CATALOG NUMBER 1005000000 REPORTED FOR THIS COMPLAINT WERE ACCIDENTALLY SUBMITTED INTO THE COMPLAINT HANDLING SYSTEM TWICE FOR THE EXACT SAME COMPLAINT INSTANCE. PLEASE REFER TO MFR REPORT # 0001831750-2013-03237FOR FULL REPORTING OF SERIAL NUMBER (B)(4) AND CATALOG NUMBER 1005000000 FOR THIS COMPLAINT.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE PATIENT RIGHT SIDE RAIL IS BROKEN AND WILL NOT LATCH IN PLACE DUE TO A BROKEN TOP RAIL AND LATCHING SPINDLE AND THE BRAKES ARE NOT HOLDING DUE TO WORN BRAKE RINGS. 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
    204036 SM104 MSERIES W5TH WHLOBS3/07 STRETCHER, WHEELED FPO STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1