BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 3792222 · Received January 13, 2014

    Report

    Report Number
    1720753-2014-00425
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    January 3, 2014
    Report Date
    January 13, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE HIGH VOLTAGE TANK WAS REPLACED AND A GENERATOR CALIBRATION WAS PERFORMED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM WAS ARCING, WHICH CAUSED THE SYSTEM TO LOCK UP. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THE EVENT DESCRIBED IN THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33320 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1