BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOSHIBA

    MDR report key: 2141788 · Received June 27, 2011

    Report

    Report Number
    2020563-2011-00012
    Event Type
    Injury
    Date Received
    June 27, 2011
    Date of Event
    May 9, 2011
    Report Date
    June 3, 2011
    Manufacturer
    TOSHIBA MEDICAL SYSTEMS CORPORATION
    Product Code
    JAA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT OCCURRED ON (B)(6) 2011, BUT NOT REPORTED TO THE HOSPITAL'S OCCUPATIONAL HEALTH DEPARTMENT UNTIL (B)(6) 2011. THE INCIDENT WAS REPORTED TO A TOSHIBA EMPLOYEE ON (B)(6) 2011. THE HOSPITAL'S OCCUPATIONAL HEALTH DEPARTMENT FILED A REPORT WITH (B)(6) AND RECOMMENDED USING BRIGHTLY COLORED TAPE AROUND THE MONITOR BOOM. RESULTS: THE PRODUCT WAS FOUND NOT TO BE DEFECTIVE AND PERFORMED AS DESIGNED. CONCLUSIONS: THE INCIDENT WAS CAUSED BY THE HOSPITAL EMPLOYEE BANGING HER HEAD ON THE MONITOR STAND.

    Description of Event or Problem · 1

    A NURSE REPORTED BANGING HER HEAD ON THE MONITOR STAND DURING A PROCEDURE. SHE CLAIMED TO HAVE PAIN UNDER HER EYE AND REQUIRED AN X-RAY. THE X-RAY SHOWED NO FRACTURE AND SHE WAS ABLE TO CONTINUE WORKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOSHIBA FLUOROSCOPIC X-RAY SYSTEM JAA TOSHIBA MEDICAL SYSTEMS CORPORATION DFP-8000D

    Patients

    Seq Age Sex Outcome Treatment
    1 Other