BEUDAMED
    FDA Adverse Event Summary report: N

    PROTEUS XR/A

    MDR report key: 3904729 · Received May 26, 2014

    Report

    Report Number
    3904729
    Date Received
    May 26, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 12, 2014
    Manufacturer
    GE HEALTHCARE
    Product Code
    KPR
    Report Source
    User Facility report
    Reporter Location
    LA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A PATIENT WAS BEING POSITIONED FOR AN X-RAY OF THE LUMBAR SPINE ON THE X-RAY TABLE, WHEN SUDDENLY SPARKS CAME OUT OF THE CABLE WIRES OF THE X-RAY TUBE. THE X-RAY TECH IMMEDIATELY SHUT THE MACHINE OFF. THERE WERE NO INITIAL PROBLEMS WITH THE DEVICE, TO OUR KNOWLEDGE, OTHER THAN THE FACT THE EQUIPMENT IS OLD (1993). THERE WERE NO INJURIES TO THE PATIENT OR THE X-RAY TECH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310057 PROTEUS XR/A SYSTEM, X-RAY, STATIONARY KPR GE HEALTHCARE MVP *

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR