BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOMATOM X.CEED

    MDR report key: 15454732 · Received September 20, 2022

    Report

    Report Number
    3004977335-2022-40657
    Event Type
    Malfunction
    Date Received
    September 20, 2022
    Date of Event
    August 9, 2022
    Report Date
    December 16, 2022
    Manufacturer
    SIEMENS HEALTHCARE GMBH-CT
    Product Code
    JAK
    UDI-DI
    04056869231051
    PMA / PMN Number
    K211373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS IS CONDUCTING A THOROUGH INVESTIGATION OF THE REPORTED EVENTS. AS THIS EVENT IS UNDER INVESTIGATION, A ROOT CAUSE HAS NOT YET BEEN DETERMINED. A SUPPLEMENT REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    SIEMENS HAS COMPLETED AN INVESTIGATION OF THE EVENT. ASSESSMENT DOES NOT INDICATE A SYSTEM FAILURE OR MALFUNCTION AND NO NON-CONFORMITY WAS IDENTIFIED. THE SYSTEM WORKS AS SPECIFIED. THE ILG LASERS SELECTION FOR NEEDLE PATH DISPLAY WAS NOT SUITABLE FOR THE GIVEN PATIENT CONTOUR. THE ENTRY POINT WAS COVERED BY THE PATIENT AND THE "EXIT" POINT WAS VISIBLE INSTEAD. THE CLINIC STAFF PREPARED THE PATIENT FOR INTERVENTION BASED ON THE INCORRECTLY DISPLAYED LASER MARK AND HAD TO REDO THE PREPARATION WHEN THE PHYSICIAN CAME AND RECOGNIZED THE OBVIOUS DISCREPANCY BETWEEN PLANNED AND VISUALIZED ENTRY POINT. THIS PROBLEM MAY OCCUR IN SPECIAL COMBINATIONS OF PATIENT CONTOUR AND PLANNED NEEDLE PATH, DUE TO ALGORITHMICALLY/CONCEPTIONAL ISSUES AND INCORRECT EXPECTATION OF THE CUSTOMER. THE PRODUCT MEETS THE SPECIFICATION. IN THE INSTRUCTIONS FOR USE FOR THE VERSION VA40A, IT IS MENTIONED THAT THE LASER GUIDANCE FEATURE IS INTENDED AS AN ORIENTATION AID. THE FOLLOWING CAUTIONS ARE INCLUDED IN THE IFU: CAUTION: INTERVENTION IS BASED ON NEEDLE PATH VISUALIZATION ONLY! INJURY TO THE PATIENT. ALWAYS PERFORM CONTROL SCANS TO COMPARE THE ACTUAL NEEDLE POSITION WITH THE ANATOMICAL LANDMARKS. THE FINAL DECISION IS YOUR RESPONSIBILITY. THE LASER GUIDANCE FEATURE IS INTENDED AS AN ORIENTATION AID. CAUTION: WRONG POSITIONING VALUES TRANSFERRED TO THE LASER SYSTEM! WRONG POSITIONING OF THE NEEDLE. TO ENSURE ACCURACY OF THE LASER MARKING: PERFORM THE QUALITY ASSURANCE PROCEDURE REGULARLY. PERFORM THE QUALITY ASSURANCE PROCEDURE AFTER ANY CHANGE TO THE LASER SYSTEM OR THE TABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE SOMATOM X.CEED CT SYSTEM. IT WAS REPORTED THAT THE ILG LASERS SELECTION FOR NEEDLE PATH DISPLAY WAS NOT SUITABLE FOR THE GIVEN PATIENT CONTOUR. THE ENTRY POINT WAS COVERED BY THE PATIENT AND THE "EXIT" POINT WAS VISIBLE INSTEAD. THE CLINIC STAFF PREPARED THE PATIENT FOR INTERVENTION BASED ON THE INCORRECTLY DISPLAYED LASER MARK. PREPARATION WAS REPEATED WHEN THE PHYSICIAN RECOGNIZED THE OBVIOUS DISCREPANCY BETWEEN PLANNED AND VISUALIZED ENTRY POINT. THIS PROBLEM MAY OCCUR IN SPECIAL (RARE) COMBINATIONS OF PATIENT CONTOUR AND PLANNED NEEDLE PATH. WE ARE UNAWARE OF ANY IMPACT TO THE STATE OF HEALTH OF THE PATIENT INVOLVED. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION IN ORDER TO CONDUCT AN INVESTIGATION OF THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2697792 SOMATOM X.CEED SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED JAK SIEMENS HEALTHCARE GMBH-CT 11330002 04056869231051

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown