BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 2914943 · Received December 20, 2012

    Report

    Report Number
    1720753-2012-10714
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    December 3, 2012
    Report Date
    December 20, 2012
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE HIGH VOLTAGE CABLE WAS REPLACED DURING THE SERVICE CALL. 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 HAD LOW MA ERRORS AND A KV ON IN ERROR, ALSO JUMPING IMAGES. THE KV ON IN ERROR MESSAGE MAY CAUSE THE SYSTEM TO SHUT DOWN UNCOMMANDED. THERE WAS NO PATIENT INJURY OR DEATH REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1