BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9600

    MDR report key: 3001886 · Received February 12, 2013

    Report

    Report Number
    1720753-2013-01704
    Event Type
    Malfunction
    Date Received
    February 12, 2013
    Date of Event
    January 31, 2013
    Report Date
    February 12, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP EVALUATED THE SYS AND RESEATED POWER SUPPLY CONNECTORS. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED BOOST MODE CREATED A SATURATION FAULT ERROR MESSAGE. THIS LIKELY TO RESULT IN A LOCK UP SITUATION. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    61354 9600 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9600

    Patients

    Seq Age Sex Outcome Treatment
    1