BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2800

    MDR report key: 3171976 · Received June 10, 2013

    Report

    Report Number
    1720753-2013-06927
    Event Type
    Malfunction
    Date Received
    June 10, 2013
    Date of Event
    May 9, 2013
    Report Date
    June 10, 2013
    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

    A GE REP EVALUATED THE SYSTEM AND REPLACED THE SYSTEM INTERFACE BOARD, THE HAND SWITCH, AND THE 5 VOLT POWER SUPPLY. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYSTEM DISPLAYED A COMMUNICATION ERROR. THIS ERROR WILL CAUSE THE SYSTEM TO LOCKUP, SHUT DOWN, OR NOT TO BOOT. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261577 2800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 2800

    Patients

    Seq Age Sex Outcome Treatment
    1