BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 3832628 · Received March 27, 2014

    Report

    Report Number
    1720753-2014-02732
    Event Type
    Malfunction
    Date Received
    March 27, 2014
    Date of Event
    March 6, 2014
    Report Date
    March 27, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN OVER THE PHONE INVESTIGATION. REPLACEMENT GENERATOR BATTERIES WERE SENT TO THE CUSTOMER. THE CUSTOMER REPLACED THE GENERATOR BATTERIES. THE SYSTEM WAS FOUND TO BE WORKING AS INTENDED. THE SYSTEM WAS PUT BACK INTO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM EXHIBITED 'PRE-CHARGE VOLTAGE ERRORS' UPON SYSTEM START UP. THIS ERROR IS LIKELY TO PREVENT THE SYSTEM FROM BOOTING TO A USABLE STATE. NO PATIENT DEATH OR SERIOUS INJURY WAS REPORTED RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179453 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1