BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2800

    MDR report key: 2043378 · Received March 28, 2011

    Report

    Report Number
    1720753-2011-02886
    Event Type
    Malfunction
    Date Received
    March 28, 2011
    Date of Event
    March 14, 2011
    Report Date
    March 28, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR'S SVC REP CONTACTED THE CUSTOMER. THE EMERGENCY STOP SWITCH WAS RESET, AND THE SYS REBOOTED. THE SYS WAS TESTED AND OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE 2800 SYS BATTERY BACK UP WAS BEEPING. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 2800

    Patients

    Seq Age Sex Outcome Treatment
    1