BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 2193215 · Received July 21, 2011

    Report

    Report Number
    1720753-2011-20263
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    July 8, 2011
    Report Date
    July 21, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE SERVICE REP CONDUCTED AN ONSITE INVESTIGATION. THE EMERGENCY SHUT DOWN KIT WAS TESTED. NO FURTHER SERVICE INFO WAS PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM WOULD NOT SAVE AN IMAGE. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1