BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800Q

    MDR report key: 3192240 · Received June 20, 2013

    Report

    Report Number
    1720753-2013-07400
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Date of Event
    June 13, 2013
    Report Date
    June 20, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SVC REP PERFORMED AN ON SITE INVESTIGATION. A SYS RESET WAS PERFORMED, THE IMAGE SYS WAS RECALIBRATED, AND CABLES AND CIRCUIT BOARDS WERE RESEATED. THE SYS WAS THEN FOUND TO BE OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYS SWITCHED OFF DURING A SCAN AND WOULD NOT BOOT BACK UP. THERE IS NO REPORT OF PT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281532 9800Q FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1