BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7900

    MDR report key: 1981580 · Received January 31, 2011

    Report

    Report Number
    9680959-2011-00206
    Event Type
    Malfunction
    Date Received
    January 31, 2011
    Date of Event
    November 15, 2010
    Report Date
    January 31, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS GMBH
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP EVALUATED THE SYSTEM AND REPLACED THE COMMUNICATIONS CIRCUIT BOARD. SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM TAKES A LONG TIME TO BOOT UP, THEN SHUTS ITSELF DOWN AFTER SEVERAL MINUTES. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 7900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS GMBH 7900

    Patients

    Seq Age Sex Outcome Treatment
    1