BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9600

    MDR report key: 1921831 · Received December 8, 2010

    Report

    Report Number
    1720753-2010-04528
    Event Type
    Malfunction
    Date Received
    December 8, 2010
    Date of Event
    November 18, 2010
    Report Date
    December 8, 2010
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE VOLTAGES WERE VERIFIED AND THE CIRCUIT BOARDS RESEATED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM INTERMITTENTLY FAILED TO PRODUCE FLUOROSCOPY. NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9600 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9600

    Patients

    Seq Age Sex Outcome Treatment
    1