BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SM204 M-SERIES W/BIG WHEEL

    MDR report key: 3071376 · Received April 22, 2013

    Report

    Report Number
    0001831750-2013-03633
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    October 1, 2012
    Report Date
    March 26, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE SIDE RAIL COULD NOT REMAIN LATCHED DUE TO FOOTEND SPINDLE SPACER AND HEAD END SPINDLE SPACER BEING BROKEN AND WORN PIVOT BLOCK. 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
    173002 SM204 M-SERIES W/BIG WHEEL STRETCHER, WHEELED FPO STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1