BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 2800012 · Received October 17, 2012

    Report

    Report Number
    1720753-2012-08387
    Event Type
    Malfunction
    Date Received
    October 17, 2012
    Date of Event
    September 21, 2012
    Report Date
    October 17, 2012
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE BATTERY 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 THAT THERE WAS A PRELOAD VOLTAGE ERROR. THIS ERROR WILL LIKELY PREVENT THE SYSTEM FROM BOOTING. THERE IS REPORT OF PT INJURY OR DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1