BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7700

    MDR report key: 1446909 · Received August 24, 2009

    Report

    Report Number
    9680959-2009-00219
    Event Type
    Malfunction
    Date Received
    August 24, 2009
    Date of Event
    June 8, 2009
    Report Date
    June 12, 2009
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). RESULTS: DAP. THE GE SVC REP CALIBRATED THE DAP. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE DAP WAS NOT CALIBRATED. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 7700 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1