BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 2884847 · Received December 3, 2012

    Report

    Report Number
    1720753-2012-09906
    Event Type
    Malfunction
    Date Received
    December 3, 2012
    Date of Event
    November 14, 2012
    Report Date
    November 30, 2012
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE X-RAY TUBE WAS REPLACED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM WAS ARCING AND DISPLAYED OVERLOAD FAULTS DURING PROCEDURES AND CONCLUDED THAT THE X-RAY TUBE NEEDED REPLACEMENT. THIS ERROR MAY CAUSE THE SYSTEM TO SHUT DOWN. THERE IS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1