BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SM304 M-SERIES W/ZOOM

    MDR report key: 3073123 · Received April 23, 2013

    Report

    Report Number
    0001831750-2013-03663
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    March 27, 2013
    Report Date
    March 27, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    INK
    PMA / PMN Number
    K022309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PREVIOUS MDR INITIAL REPORT WAS FILED WITHOUT THE PMA/510(K)#. THIS FOLLOW-UP MDR IS BEING ISSUED WITH THE PMA/510(K)# INCLUDED. ADDITIONALLY, UPON COMPLETION OF THE MANUFACTURER'S INVESTIGATION, IT WAS DETERMINED THAT THE BATTERIES WERE NOT ABLE TO CHARGE AND THE ZOOM DRIVE WOULD NOT BE ABLE TO BE ENGAGED AS A RESULT. HOWEVER, THE UNIT WOULD STILL BE MOBILE MANUALLY.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE ZOOM DISENGAGES DURING USE DUE TO MALFUNCTIONED BATTERIES. 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 DISENGAGES DURING USE DUE TO MALFUNCTIONED BATTERIES. 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
    173397 SM304 M-SERIES W/ZOOM STRETCHER, WHEELED, POWERED INK STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1