BEUDAMED
    FDA Adverse Event Injury Summary report: N

    I-PORTAL NEURO-OTOLOGICAL TEST CENTER

    MDR report key: 2460621 · Received February 16, 2012

    Report

    Report Number
    2519945-2011-00001
    Event Type
    Injury
    Date Received
    February 16, 2012
    Date of Event
    October 21, 2011
    Report Date
    October 21, 2011
    Manufacturer
    NEURO-KINETICS INC.
    Product Code
    GWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NEURO-KINETICS RECEIVED NO FORMAL REPORT FROM (B)(6) OF THE EVENT. NEURO-KINETICS BECAME AWARE OF THE EVENT FROM A PHONE CALL FROM (B)(6) (A CLINICIAN) THAT THEIR DEVICE MAY NEED SERVICED AFTER AN INJURY HAD OCCURRED. THE CALL WAS (B)(6) JUST PRIOR TO MY (B)(6) SCHEDULED ANNUAL PREVENTIVE MAINTENANCE AND SAFETY INSPECTION. HE INFORMED ME THAT THE PT DID NOT HAVE THE FOOT OR KNEE RESTRAINT IN PLACE TO PREVENT HIS LEGS FROM BEING PULLED OUTWARD BY THE CENTRIFUGAL FORCE. NEURO-KINETICS DID NOT RECEIVE ANY INFO ON THE SERIOUSNESS OF THE INJURY AND THUS CANNOT BE SURE WHETHER THE THRESHOLD OF "SERIOUS INJURY" HAS BEEN MET, BUT WE ARE FILING THE REPORT IN AN ABUNDANCE OF CAUTION AND ARE CONTINUING TO INVESTIGATE. THE FINDINGS OF THE DEVICE INSPECTION WERE: THE SEAT BELTS AND SHOULDER BELTS SHOW SLIGHT WEAR ON THE EDGES AT THE ADJUSTMENT POINTS BUT WERE SOUND AND SECURE. THE BELT ADJUSTMENT HARDWARE ADJUSTED FREELY AND LOCKED TIGHT WHEN PULLED ON. BUCKLES AND ANCHOR POINTS WERE INSPECTED, SHOWED NO SIGNS WEAR OR FATIGUE AND FUNCTIONED AS DESIGNED. THE FOOT RESTRAINTS WERE FOUND IN A GOOD FUNCTIONAL CONDITION AND FUNCTIONED AS DESIGNED; ALL FASTENERS WERE FOUND TO BE TIGHT AND THE RATCHETING MECHANISM FUNCTIONED PROPERLY. THE OPERATOR'S STATION WAS SET UP EFFICIENTLY WITH THE E-STOP BUTTON ACCESSIBLE WHILE THE PT VIEWING MONITOR IS IN OPERATOR'S SIGHT. IT IS IMPORTANT TO NOTE THAT THE E-STOP IS THE ULTIMATE SAFETY MEASURE, DESIGNED FOR SITUATIONS EXACTLY LIKE THIS TO EXECUTE AN IMMEDIATE STOP. TECHNICIAN RAN A FULL AND THOROUGH SET OF TESTS INSPECTING ALL PLC FUNCTIONS, LIMITS, AND INTERLOCKS. ALL WERE INSPECTED AND FOUND IN PROPER WORKING CONDITION. THE SYSTEM FUNCTIONED AS DESIGNED. FURTHER INVESTIGATION PENDING INFO FROM USER.

    Description of Event or Problem · 1

    THE EVENT OCCURRED IN THE I-PORTAL NEURO-OTOLOGICAL TEST CENTER LOCATED AT (B)(6). IT APPEARS THAT THE SYSTEM OPERATOR FAILED TO PROPERLY SECURE THE PATENT BEFORE TESTING, CAUSING THE PT TO COME OUT OF THE CHAIR AT A HIGH SPEED OF ROTATION. NEURO-KINETICS HAS LIMITED INFO OF THE EVENT FROM THE USER. MORE INVESTIGATION TO FOLLOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 I-PORTAL NEURO-OTOLOGICAL TEST CENTER NOTC ROTATIONAL CHAIR GWN NEURO-KINETICS INC. RCS-365 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization