BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEGACY SPOT FILM DEVICE

    MDR report key: 282250 · Received June 15, 2000

    Report

    Report Number
    2126677-2000-00006
    Event Type
    Injury
    Date Received
    June 15, 2000
    Date of Event
    May 16, 2000
    Report Date
    June 14, 2000
    Manufacturer
    GE MEDICAL SYSTEMS
    Product Code
    JAA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO GEMS THAT WHEN THE TABLE WAS IN THE HORIZONTAL POSITION AND WHEN THE TECH WENT TO MOVE THE TOWER, TECH HEARD A LOUD NOISE AND THE SPOT FILM DEVICE (SFD) CAME DOWN. THERE WAS A PT ON THE TABLE. THE PT SUSTAINED BRUISES TO THE NOSE AND HAD TO HOLD BARIUM FOR APPROX 10 MINUTES DUE TO THE INCIDENT. PT COMPLAINED OF ABDOMINAL PAIN. THE PT WAS TAKEN TO ER AND RELEASED THE SAME DAY. THE MAIN HEAD COUNTERWEIGHT PULLEY WAS OBSERVED TO BE WORN OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEGACY SPOT FILM DEVICE DIAGNOSTIC X-RAY JAA GE MEDICAL SYSTEMS 46-262751G8 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other