BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIMA NM/CT 640

    MDR report key: 3839178 · Received May 15, 2014

    Report

    Report Number
    9613299-2014-00002
    Event Type
    Injury
    Date Received
    May 15, 2014
    Date of Event
    April 16, 2014
    Report Date
    April 18, 2014
    Manufacturer
    GE MEDICAL SYSTEMS ISRAEL
    Product Code
    KPS
    PMA / PMN Number
    K121019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 TECHNOLOGIST HAD TRIPPED ON A SYSTEM FLOOR PUCK AND HAD FALLEN HEAD FIRST TOWARDS THE ROOM DOOR. AS A RESULT OF THE FALL, THE TECHNOLOGIST SUFFERED A LACERATION IN THE HEAD AND RECEIVED STAPLE SUTURES AS A TREATMENT FOR THE INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289277 OPTIMA NM/CT 640 TOMOGRAPHY, COMPUTED, EMISSION KPS GE MEDICAL SYSTEMS ISRAEL

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other