BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SM304 M-SERIES W/ZOOM

    MDR report key: 3201985 · Received July 2, 2013

    Report

    Report Number
    0001831750-2013-05958
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    May 27, 2013
    Report Date
    June 3, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    INK
    PMA / PMN Number
    K022309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PREVIOUS MDR INITIAL REPORT WAS ISSUED WITHOUT THE PMA/510(K)#. THIS FOLLOW-UP MDR REPORT INCLUDES THE PMA/510(K)#. ADDITIONALLY, UPON COMPLETION OF THE MANUFACTURER'S INVESTIGATION IT WAS DETERMINED THAT THE SIDE RAIL COULD NOT REMAIN LATCHED DUE TO A DAMAGED SPRING SPACER.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE SIDE RAIL MAY NOT HAVE BEEN ABLE TO LATCH. MANUFACTURER'S INVESTIGATION IS ONGOING. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT MAY BE ISSUED. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE SIDE RAIL MAY NOT HAVE BEEN ABLE TO LATCH. MANUFACTURER'S INVESTIGATION IS ONGOING. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT MAY BE ISSUED. 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
    302098 SM304 M-SERIES W/ZOOM STRETCHER, WHEELED, POWERED INK STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1