BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTRAK 2500

    MDR report key: 2193499 · Received July 21, 2011

    Report

    Report Number
    1720753-2011-20278
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    July 7, 2011
    Report Date
    July 21, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS
    Product Code
    LLZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SVC REP PERFORMED AN OVER THE PHONE INVESTIGATION. TECHNICAL SUPPORT WAS PROVIDED TO THE CUSTOMER TO PERFORM A DATABASE DIRECTORY REVIEW FOLLOWED BY THE DATABASE RECOVERY. A CMOS BATTERY REPLACEMENT IS NEEDED TO RESOLVE THE LACK OF AUTOMATIC BOOT UP PROCESS. NO CONCLUSION CAN BE DRAWN AS REPAIR INFO IS UNAVAILABLE AND NO ADD'L SERVICE INFO WAS PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM'S MOUSE OR CONTROL WOULD NOT WORK CORRECTLY AND THE DATABASE WAS NOT ACCESSIBLE. THE SYSTEM WOULD NOT BOOT UP AUTOMATICALLY WHICH MAY BE A CMOS BATTERY ISSUE. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENTRAK 2500 RADIOLOGICAL IMAGE PROCESSING LLZ GE OEC MEDICAL SYSTEMS ENTRAK2500

    Patients

    Seq Age Sex Outcome Treatment
    1