BEUDAMED
    FDA Adverse Event Summary report: N

    VIVIDIMAGE T 26" SURGICAL GRADE MONITOR

    MDR report key: 4899427 · Received July 8, 2015

    Report

    Report Number
    1000404456-2015-00005
    Date Received
    July 8, 2015
    Date of Event
    June 12, 2015
    Report Date
    July 8, 2015
    Manufacturer
    VTS MEDICAL SYSTEMS
    Product Code
    KQM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    STERIS WAS INFORMED THAT THE SURGICAL MONITOR DID NOT FALL OR MOVE INTO THE EMPLOYEE AND THAT THIS EVENT WAS THE RESULT OF INATTENTIVENESS. THE SURGICAL MONITOR DID NOT SUSTAIN ANY DAMAGE AS A RESULT OF THE INCIDENT AND IS OPERATING ACCORDING TO SPECIFICATION.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED AN EMPLOYEE INATTENTIVELY HIT HIS HEAD ON A VIVIDIMAGE T 26" SURGICAL GRADE MONITOR. THE EMPLOYEE MOVED UP AND INTO THE MONITOR AND LOST CONSCIOUSNESS. THE EMPLOYEE HAD A VISIBLE LUMP ON HIS HEAD AND COMPLAINED OF KNEE PAIN. THE EMPLOYEE SUBJECT OF THE REPORTED EVENT SOUGHT MEDICAL TREATMENT AND WAS SENT HOME AS A PRECAUTIONARY MEASURE. THE EMPLOYEE RETURNED TO FULL AND NORMAL WORK DUTIES THE NEXT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444580 VIVIDIMAGE T 26" SURGICAL GRADE MONITOR MONITOR KQM VTS MEDICAL SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other