BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 2941163 · Received January 18, 2013

    Report

    Report Number
    1720753-2013-00829
    Event Type
    Malfunction
    Date Received
    January 18, 2013
    Date of Event
    January 10, 2013
    Report Date
    January 18, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REPRESENTATIVE EVALUATED THE SYSTEM AND REPLACED THE BATTERIES, BATTERY CHARGER, AND THE POWER CAP MODULE. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THERE WAS A PRECHARGE VOLTAGE ERROR AND THE SYSTEM WOULD NOT FUNCTION. THIS ERROR WILL LIKELY PREVENT THE SYSTEM FROM BOOTING. 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
    28384 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1