BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INNOVA 3100

    MDR report key: 957366 · Received December 4, 2007

    Report

    Report Number
    9611343-2007-00099
    Event Type
    Malfunction
    Date Received
    December 4, 2007
    Date of Event
    October 25, 2007
    Report Date
    December 4, 2007
    Manufacturer
    GE MEDICAL SYSTEMS SCS
    Product Code
    IZI
    PMA / PMN Number
    K052412
    Removal / Correction Number
    Z-0870-2007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE LOGS BY THE INVESTIGATION TEAM REVEALED THAT THE ISSUE WAS CAUSED DUE TO A KNOWN "FOIB" ISSUE. IN CASE OF FAILURE DURING THE ACQUISITION OF FLUORO OR RECORD, THERE IS A FROZEN IMAGE. DURING THIS FAILURE THE SYSTEM WILL SEND X-RAY WITHOUT REPORTING ANY ERROR MESSAGE. THE X-RAY WILL REMAIN WITH THE FROZEN IMAGE UNTIL THE OPERATOR RELEASED THE PEDAL. ONCE THE PEDAL IS RELEASED BY THE OPERATOR, THE X-RAY STOPS AS PER THE SPECIFICATION AND AN "ABORT" MESSAGE IS DISPLAYED AFTER 2.5 SECONDS AND THE IMAGE WILL GET BLACKEND. THE OPERATOR NEEDS TO DO A SHUTDOWN / POWER UP TO RECOVER THE SYSTEM. A FIELD CORRECTION HAS BEEN LAUNCHED TO UPDATE THE AFFECTED UNITS IN THE INSTALLED BASE. FDA HAS CLASSIFIED THE ACTION AS A CLASS- II RECALL.

    Description of Event or Problem · 1

    DURING A SERVICE VISIT THE FIELD SERVICE ENGINEER REPORTED THAT DL LIVE MONITOR DISPLAYS A FROZEN IMAGE. THE IMAGE CHAIN HUNG. THERE WAS AN ERROR 810006 "STOP SEQUENCE TIMED OUT". NO REPORTED PT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INNOVA 3100 VASCULAR X-RAY SYSTEM IZI GE MEDICAL SYSTEMS SCS 5198298

    Patients

    Seq Age Sex Outcome Treatment
    1 YR