BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7700

    MDR report key: 1070374 · Received July 9, 2008

    Report

    Report Number
    9680959-2008-00103
    Event Type
    Malfunction
    Date Received
    July 9, 2008
    Date of Event
    May 30, 2008
    Report Date
    June 26, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS, INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE SERVICE REP PERFORMED/COMPLETED GENERATOR CALIBRATION. AFTER PERFORMING GENERATOR CAL, ENTRANCE DOSE OUTPUT IS STILL 30% LOW. ALSO, THE AUTO TECHNIQUE TRACKING VALUES WERE AS FOLLOWS: AT 1 COPPER FILTER - 69KVP AT 2 COPPER FILTER - 79KVP AT 3 COPPER FILTER - 86KVP. NEW READINGS FOR AUTO TECHNIQUE TRACKING IS AS FOLLOWS: AT 1 COPPER FILTER - 61KVP AT 2 COPPER FILTER - 71KVP AT 3 COPPER FILTER - 78KVP ADJUSTED CAMERA IRIS TO BRING AUTO TECHNIQUE TRACKING INTO SPEC. ALL VALUES SAVED ON COMPACT 7700 PMI E-CHECKLIST. RECOMMEND CUSTOMER TO REPLACE THE MONOBLOCK ASSEMBLY. CUSTOMER DOES NOT WISH TO REPLACE MONOBLOCK ASSEMBLY AT THIS TIME.

    Description of Event or Problem · 1

    THE GE SERVICE TECH FOUND AUTO TECHNIQUE TRACKING IS OUT OF SPEC. 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