BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2800

    MDR report key: 2093046 · Received May 3, 2011

    Report

    Report Number
    1720753-2011-06842
    Event Type
    Malfunction
    Date Received
    May 3, 2011
    Date of Event
    April 13, 2011
    Report Date
    May 3, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP CONDUCTED AN ONSITE INVESTIGATION. THE FAST STOP BUTTON HAD BEEN PUSHED ON THE GENERATOR. THE SYSTEM WAS OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM DISPLAYED A FAST STOP BUTTON PUSHED ERROR MESSAGE. 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