BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SM304 M-SERIES W/ZOOM

    MDR report key: 3200776 · Received July 1, 2013

    Report

    Report Number
    0001831750-2013-05943
    Event Type
    Malfunction
    Date Received
    July 1, 2013
    Date of Event
    May 30, 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
    VA, 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, IT WAS PREVIOUSLY REPORTED THAT THE ZOOM HANDLE COVERS WERE DAMAGED. UPON COMPLETION OF THE MANUFACTURER'S INVESTIGATION IT WAS DETERMINED THAT THE ISSUE WAS THAT THE LITTER CORNER COVER WAS DAMAGED WITH EXPOSED SHARP EDGES REPORTED. THERE WAS NO REPORTED DEFECT FROM THE ZOOM HANDLES.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE ZOOM HANDLES WERE BROKEN RESULTING IN SHARP EDGES BEING EXPOSED. 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 ZOOM HANDLES WERE BROKEN RESULTING IN SHARP EDGES BEING EXPOSED. 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
    298809 SM304 M-SERIES W/ZOOM STRETCHER, WHEELED, POWERED INK STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1