BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAIR PRO - MODEL 6252

    MDR report key: 3070861 · Received April 22, 2013

    Report

    Report Number
    0001831750-2013-03607
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    March 25, 2013
    Report Date
    March 25, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FPP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS IS A DUPLICATE OF MFR REPORT # 0001831750-2013-03609. THE SERIAL NUMBER (B)(4) AND CATALOG NUMBER 6252000000 REPORTED FOR THIS COMPLAINT WAS ACCIDENTALLY SUBMITTED INTO THE COMPLAINT HANDLING SYSTEM TWICE FOR THE EXACT SAME COMPLAINT INSTANCE. PLEASE REFER TO MFR REPORT # 0001831750-2013-03609 FOR FULL REPORTING OF SERIAL NUMBER (B)(4) AND CATALOG NUMBER 6252000000 FOR THIS COMPLAINT.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE TRACKS WILL NOT ENGAGE THE STAIRS PROPERLY DUE TO WORN TRACKS. 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
    172534 STAIR PRO - MODEL 6252 STRETCHER, HAND-CARRIED FPP STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1