BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEMINI GXL

    MDR report key: 5002185 · Received August 13, 2015

    Report

    Report Number
    1525965-2015-00224
    Event Type
    Malfunction
    Date Received
    August 13, 2015
    Report Date
    July 14, 2015
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
    Product Code
    KPS
    PMA / PMN Number
    K051170
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ON (B)(6) 2015, THE CUSTOMER REPORTED THAT POSITION ON THE TREATMENT LASER POINTER IS OFF AND MISALIGNED. THERE WAS NO REPORT OF HARM TO A PATIENT, OPERATOR OR BYSTANDER FROM THIS ISSUE. THERE WAS NO IMAGE MISINTERPRETATION REPORTED AS A RESULT OF THIS EVENT. FURTHER INVESTIGATION INTO THIS ISSUE DETERMINED THAT THE TABLE TOP WAS MISALIGNED WITH THE INTERNAL CT SYSTEM LASERS. THE SYSTEM WAS IN CLINICAL USE WHEN THIS ISSUE WAS DETECTED. THE PHILIPS FIELD SERVICE ENGINEER (FSE) CONFIRMED THAT THERE WAS NO NEED FOR A PATIENT RESCAN AND THE OPERATOR WAS ABLE TO WORK AROUND THE MISALIGNMENT. THE OPERATOR WAS USING THE PATIENT INDEX BUTTON ON THE CONTROL PANEL WHEN THEY NOTICED THE TABLE TOP WAS MISALIGNED WITH THE INTERNAL CT LASERS BY A VALUE OF 1841 MILLIMETERS WITH REGARDS TO THE EXPECTED POSITION THE TABLE WAS PLANNED TO BE. THE PHILIPS FSE CONFIRMED WITH THE OPERATOR THAT THE ISSUE WAS EASILY DETECTABLE TO THE USER. THE PHILIPS FSE STATED THAT THE MISALIGNMENT WAS CAUSED BY THE PHILIPS FSE FAILING TO PROPERLY RESTORE THE REGISTRY FILE FOR THE LASER GAP AFTER A REPLACEMENT OF THE CT HOST COMPUTER AS DESCRIBED IN GEMINI GXL SERVICE MANUAL FOR SOFTWARE INSTALLATION. THE FSE PROPERLY UPDATED THE LASER GAP REGISTRY VALUE TO CORRECT THIS ISSUE. IT WAS CONFIRMED THAT THE SYSTEM WAS OPERATING WITHOUT ANY ISSUE AFTER THE CORRECTION WAS PERFORMED BY THE FSE. THE OVERALL RISK IS BASED ON ENGINEER'S INVESTIGATION AND ACCORDING TO THE RISK ASSESSMENT THIS REPORTED EVENT WAS DETERMINED TO BE OF ACCEPTABLE RISK. IT HAS BEEN CONCLUDED THAT IF THIS EVENT WERE TO RECUR IT WOULD NOT BE LIKELY TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY. BASED UPON THE INFORMATION PROVIDED, THIS ISSUE WAS CAUSED BY THE PHILIPS FSE FAILING TO PROPERLY UPDATE THE REGISTRY FILE ON THE CT HOST COMPUTER AFTER A CT HOST COMPUTER REPLACEMENT AS DESCRIBED IN THE GEMINI GXL SERVICE MANUAL FOR SOFTWARE INSTALLATION.

    Additional Manufacturer Narrative · 1

    (B)(4). NOTE: WE HAVE NOT COMPLETED OUR INVESTIGATION OF THIS EVENT. WE WILL FILE A FOLLOW-UP EMDR AT THE COMPLETION OF THE INVESTIGATION. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE POSITION ON THE TREATMENT LASER POINTER WAS OFF AND MISALIGNED (THE DISTANCE FROM THE EXTERNAL TREATMENT LASER TO THE CT-SIDE ISO CENTER (LASER GAP). THERE WAS NO REPORT OF HARM TO A PATIENT, OPERATOR OR BYSTANDER FROM THIS ISSUE. A THIRD PARTY FIELD SERVICE ENGINEER (FSE) ADJUSTED THE GAP TO RESOLVE THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533825 GEMINI GXL SYSTEM, TOMOGRAPHY, COMPUTED, EMISSION KPS PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. 882390

    Patients

    Seq Age Sex Outcome Treatment
    1