BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6800

    MDR report key: 4801862 · Received May 26, 2015

    Report

    Report Number
    1720753-2015-02232
    Event Type
    Malfunction
    Date Received
    May 26, 2015
    Date of Event
    May 12, 2015
    Report Date
    May 26, 2015
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SVC REP PERFORMED AN ON SITE INVESTIGATION. THE HARD DISK DRIVE WAS EVALUATED AND REPLACED. THE SYS SOFTWARE AND CALIBRATIONS WERE ALSO RELOADED DURING THE SVC EVENT TO VERSION 10. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND RETURNED TO SVC.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYS FAILED TO BOOT AND EXHIBITED A NON-RECOVERABLE LOSS OF FUNCTIONALITY. NO PT SERIOUS INJURY OR DEATH WAS REPORTED RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341032 6800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 6800 86-0296

    Patients

    Seq Age Sex Outcome Treatment
    1