BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800MD

    MDR report key: 1071115 · Received July 10, 2008

    Report

    Report Number
    1720753-2008-22894
    Event Type
    Malfunction
    Date Received
    July 10, 2008
    Date of Event
    June 11, 2008
    Report Date
    June 25, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS, INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE SERVICE REP FOUND DEFECTIVE BATTERY PACK SET. THE REP REPLACED THE BATTERIES AND TESTED SYSTEM. SYSTEM OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN ERROR CODE DISPLAYED AT END OF CASE. NO PT WAS INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9800MD FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1