BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 3870007 · Received April 28, 2014

    Report

    Report Number
    1720753-2014-03713
    Event Type
    Malfunction
    Date Received
    April 28, 2014
    Date of Event
    April 4, 2014
    Report Date
    April 28, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE HV (HIGH VOLTAGE) CABLE AND IGBT PCB ASSEMBLY WERE EVALUATED AND IDENTIFIED AS REQUIRING REPLACEMENT. NO CONCLUSION CAN BE DRAWN AS CONCLUSIVE REPAIR INFORMATION IS UNAVAILABLE AT THIS TIME AND NO ADDITIONAL SERVICE INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THERE WAS A 'KV ON IN ERROR' MESSAGE DISPLAYED. THIS ERROR IS LIKELY TO RESULT IN AN IMMEDIATE LOSS OF SYSTEM FUNCTIONALITY AND AN UN-COMMANDED SHUT DOWN. THERE IS NO REPORT OF A PATIENT INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254275 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1