BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 2884863 · Received December 3, 2012

    Report

    Report Number
    1720753-2012-09890
    Event Type
    Malfunction
    Date Received
    December 3, 2012
    Date of Event
    November 13, 2012
    Report Date
    November 30, 2012
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REPRESENTATIVE EVALUATED THE SYSTEM AND DETERMINED THE INPUT POWER TRANSFORMER NEEDED TO BE ADJUSTED, BUT BECAUSE THE SYSTEM WAS GOING TO BE MOVED TO ANOTHER LOCATION (WITH POSSIBLY A DIFFERENT INPUT VOLTAGE) IT WAS DECIDED TO WAIT UNTIL AFTER THE SYSTEM WAS MOVED. NO CONCLUSION CAN BE DRAWN AS REPAIR INFORMATION IS NOT AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A MESSAGE CAME UP ON THE MONITOR ASKING THEM TO REBOOT THE SYSTEM. WHEN THEY DID THEY WERE UNABLE TO POWER IT BACK UP. THE FSE REPORTED THAT THE SYSTEM WAS PRODUCING THE INSUFFICIENT POWER ALARM. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THE EVENT DESCRIBED IN 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