BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 3960266 · Received June 24, 2014

    Report

    Report Number
    1720753-2014-05390
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Date of Event
    June 9, 2014
    Report Date
    June 23, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO CONCLUSION CAN BE DRAWN AS CONCLUSIVE REPAIR INFO IS UNAVAILABLE AT THIS TIME AND NO ADD'L SERVICE INFO WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE SYSTEM DISPLAYED A PRECHARGE FAIL ERROR MESSAGE. THIS MESSAGE WILL RESULT IN A NO BOOT SITUATION. THERE ARE NO REPORT OF PT INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367365 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1