BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 1031045 · Received April 17, 2008

    Report

    Report Number
    1720753-2008-20624
    Event Type
    Malfunction
    Date Received
    April 17, 2008
    Date of Event
    April 3, 2008
    Report Date
    April 11, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SERVICE REP CHECKED THE SYSTEM OVER AND FOUND IT INTERMITTENTLY WORKING. FOUND SYSTEM WOULD STOP FLUOROING WHEN HV CABLE ASSEMBLY WAS MOVED. CHECKED AND FOUND BROKEN VIDEO LINE NEAR THE C-PORTION OF THE HV CABLE ASSEMBLY. ORDERED NEW HV CABLE ASSEMBLY. THE REP REMOVED AND REPLACED HV CABLE ASSEMBLY. CHECKED OPERATION BY PERFORMING MULTIPLE TASKS ON THE C-ARM. EVERYTHING IS WORKING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM WAS NOT FLUOROING AND THE TECH WAS A MAX. NO PT 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