BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIMA CT660

    MDR report key: 3925620 · Received June 17, 2014

    Report

    Report Number
    2126677-2014-00010
    Event Type
    Injury
    Date Received
    June 17, 2014
    Date of Event
    May 16, 2014
    Report Date
    May 20, 2014
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    JAK
    PMA / PMN Number
    K110227
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT AGE AND WEIGHT WERE NOT PROVIDED. GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CT TECHNOLOGIST CAUGHT THEIR FOOT ON A PATIENT POSITIONING STRAP THAT WAS HANGING FROM THE CT TABLE ONTO THE FLOOR. THE TECH REPORTEDLY TRIPPED AND FELL; LANDING ON HER KNEE. SHE SUSTAINED A TORN LATERAL MENISCUS AS A RESULT OF THIS FALL AND WAS PRESCRIBED TO RECEIVE PHYSICAL THERAPY INCLUDING EXERCISE AND MANIPULATION. THERE WAS NO PLAN FOR SURGERY AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355956 OPTIMA CT660 COMPUTED TOMOGRAPHY X-RAY SYSTEM JAK GE MEDICAL SYSTEMS, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other