BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9600+

    MDR report key: 946909 · Received November 7, 2007

    Report

    Report Number
    1720753-2007-07479
    Event Type
    Malfunction
    Date Received
    November 7, 2007
    Date of Event
    October 16, 2007
    Report Date
    November 7, 2007
    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 SERVICE REP REPLACED THE VARIABLE RESISTOR (IRIS POT), CALIBRATED THE POT DC VOLTAGE TO 0.7 [V] IN COLLIMATOR CLOSED POSITION, AND TO 4.3 [V] IN THE OPEN POSITION, CLEANED AND LUBRICATED ALL THE GEARS OF THE COLLIMATOR, CHECKED THE COLLIMATOR OPERATIONS. BOOTED UNIT SEVERAL TIMES ERROR FREE, HOWEVER, IN THE FORTH BOOT-UP THE SAME ERROR OCCURRED, PROBLEM NOT TOTALLY FIXED DUE TO SOME PARTIALLY DAMAGED COMPONENT IN THE COLLIMATOR. SUGGESTED TO REPLACE COLLIMATOR TO BE DENY BY THE CUSTOMER AND ELECTED TO PROCEED WITH REPAIR.

    Description of Event or Problem · 1

    THE 9600+ UNIT DOES NOT BOOT-UP AND A BAD IROS POT ERROR DISPLAYED. DETERMINED THAT PROBLEM CAUSED BY A FAULTY VARIABLE RESISTOR POT (IRIS POT). NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9600+ FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR