BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 3033127 · Received April 1, 2013

    Report

    Report Number
    1720753-2013-04432
    Event Type
    Malfunction
    Date Received
    April 1, 2013
    Date of Event
    March 21, 2013
    Report Date
    April 1, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REPERESENTATIVE EVALUATED THE SYSTEM AND ADJUSTED THE 5 VOLT POWER SUPPLY. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM EXPERIENCED COMMUNICATION ERRORS. THIS ERROR IS LIKELY TO RESULT IN A SYSTEM LOCK UP OR PREVENT THE SYSTEM FROM BOOTING TO A USABLE STATE. THERE IS NO REPORT OF PATIENT INJURY OR DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132249 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1