BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 2934587 · Received January 10, 2013

    Report

    Report Number
    1720753-2013-00473
    Event Type
    Malfunction
    Date Received
    January 10, 2013
    Date of Event
    December 28, 2012
    Report Date
    January 10, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP EVALUATED THE SYSTEM AND REPLACED THE BATTERIES. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYSTEM HAD A CHARGE FAILED ERROR AND THAT THEY WERE ABLE TO FINISH THE CASE AFTER REBOOTING THE SYSTEM. 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
    16223 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1