BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SM304 M-SERIES W/ZOOM

    MDR report key: 3011308 · Received March 19, 2013

    Report

    Report Number
    0001831750-2013-02212
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Date of Event
    February 20, 2013
    Report Date
    February 20, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    INK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE BRAKES WOULD ENGAGE INTERMITTENTLY DUE TO A WORN BRAKE CAM. 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
    113919 SM304 M-SERIES W/ZOOM STRETCHER, WHEELED, POWERED INK STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1