BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 1973662 · Received January 18, 2011

    Report

    Report Number
    1720753-2011-00368
    Event Type
    Malfunction
    Date Received
    January 18, 2011
    Date of Event
    December 22, 2010
    Report Date
    January 18, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REPRESENTATIVE EVALUATED THE SYSTEM AND FOUND THE 5V POWER SUPPLY TO READ 4.8V ON THE C-ARM. GE REPRESENTATIVE ADJUSTED IT TO 5.23VDC. GE REPRESENTATIVE PERFORMED A FILAMENT CALIBRATION, AND COULD NOT DUPLICATE THE MA ERROR. THE CUSTOMER HAS A PORTABLE AIR CONDITIONER IN THE ROOM AND MAY ELIMINATE IT FROM POWER CONSUMPTION. MOST LIKELY IT IS PULLING AMPERAGE DOWN ON SYSTEM AND CREATING MA ERROR ON THE SYSTEM. CHECKED OVERALL OPERATION AND VERIFIED THE SYSTEM PERFORMS AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A PROCEDURE, THE SYSTEM DISPLAYED A LOW MA ERROR, STOPPED FLUORO AND BEEPED CONTINUOUSLY. THE CUSTOMER POWERED OFF SYSTEM AND REPLACED WITH ANOTHER C-ARM. NO PATIENT INJURY WAS REPORTED.

    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