BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 2891576 · Received December 7, 2012

    Report

    Report Number
    1720753-2012-10219
    Event Type
    Malfunction
    Date Received
    December 7, 2012
    Date of Event
    November 21, 2012
    Report Date
    December 7, 2012
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE HIGH VOLTAGE CONNECTORS WERE CLEANED AND REGREASED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT, WHEN PRESSING ON THE FLUORO BUTTON, THEY HEARD A CRACKING NOISE, THE KV SHOT UP, AND THEN THE SYSTEM SHUT DOWN. THERE IS NO REPORT OF PT INJURY.

    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