BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 3113053 · Received May 9, 2013

    Report

    Report Number
    1720753-2013-05872
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    January 23, 2013
    Report Date
    May 9, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO CONCLUSION CAN BE DRAWN AS REPAIR INFO IS UNAVAILABLE. HOWEVER, NO REPORT OF PT OR STAFF INJURY WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYSTEM INTERMITTENTLY WOULD NOT BOOT UP. THIS WOULD RESULT IN AN INTERMITTENT, RECOVERABLE LOSS OF IMAGING FUNCTIONALITY, WHICH COULD RESULT IN PROCEDURAL DELAYS. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204668 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1