BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 3874680 · Received April 24, 2014

    Report

    Report Number
    1720753-2014-03619
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    April 2, 2014
    Report Date
    April 24, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE BATTERY PACK WAS REPLACED DURING THE SERVICE CALL. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN INTERMITTENT 24-HOUR RECHARGE REQUIRED ERROR MESSAGE. THIS ERROR DISABLES X-RAY UNTIL THE BATTERIES ARE SUFFICIENT CHARGED TO ALLOW NORMAL OPERATION. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248355 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1