BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 1312055 · Received February 17, 2009

    Report

    Report Number
    1720753-2008-26719
    Event Type
    Malfunction
    Date Received
    February 17, 2009
    Date of Event
    September 22, 2008
    Report Date
    October 8, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE SERVICE REP FOUND THE COLLIMATOR BLADES WERE INOPERABLE. THE GE REP REPLACED THE HV CABLE FOR COLLIMATOR ISSUE AND X-RAY TUBE FOR HFL ISSUE. HE BROKE THE TEMP SENSOR CABLE REPLACING THE X-RAY TUBE THEN REPLACED THE TEMP SENSOR. SYSTEM FUNCTIONAL AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM HAD A HALF VALUE LAYER OF X-RAY TUBE TOO LOW. NO PATIENT INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1