BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 2915008 · Received December 20, 2012

    Report

    Report Number
    1720753-2012-10694
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    December 4, 2012
    Report Date
    December 20, 2012
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE INTERCONNECT CABLE WAS REPLACED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE KV INTERMITTENTLY MAXED OUT. THE FIELD ENGINEER ADDED THAT NO LIVE IMAGE WAS SHOWING ON THE LEFT MONITOR WHEN THIS OCCURRED. THERE IS NO REPORT OF PATIENT 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