BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 2900832 · Received December 12, 2012

    Report

    Report Number
    1720753-2012-10358
    Event Type
    Malfunction
    Date Received
    December 12, 2012
    Date of Event
    December 3, 2012
    Report Date
    December 12, 2012
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP EVALUATED THE SYSTEM AND RESEATED CIRCUIT BOARDS AND CONNECTORS. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE IMAGE APPEARED TO BE IN SUBTRACTION MODE; HOWEVER, THE CUSTOMER STATED THAT THEY WERE NOT IN SUBTRACTION MODE. THE CUSTOMER HAD TO USE ANOTHER C-ARM TO FINISH THE CASE DUE TO THE DEGRADATION OF THE IMAGE QUALITY. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1