BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOMATOM X.CITE

    MDR report key: 15959755 · Received December 12, 2022

    Report

    Report Number
    3004977335-2022-53446
    Event Type
    Injury
    Date Received
    December 12, 2022
    Date of Event
    October 28, 2022
    Report Date
    December 12, 2022
    Manufacturer
    SIEMENS HEALTHCARE GMBH-CT
    Product Code
    JAK
    UDI-DI
    04056869231044
    PMA / PMN Number
    K211373
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS HAS COMPLETED AN INVESTIGATION OF THE REPORTED EVENT. ASSESSMENT DOES NOT INDICATE A SYSTEM FAILURE OR MALFUNCTION AND NO NON-CONFORMITY WAS IDENTIFIED. BASED ON THE INFORMATION AVAILABLE, NO GENERAL PRODUCT PROBLEM COULD BE IDENTIFIED AND THE INVESTIGATION OF THE TABLE SHOWED THAT ALL GAP DIMENSIONS ARE WITHIN SPECIFICATION. THE INSTRUCTIONS FOR USE WAS REVIEWED AND DEEMED TO ADEQUATELY PROVIDE INSTRUCTIONS TO THE USER TO PREVENT SUCH AN EVENT. SEE EXCERPT BELOW. ACCORDING TO THE INSTRUCTIONS FOR USE (SOMATOM X.CITE I INSTRUCTIONS FOR USE; PRINT NO. C2-060A-G.621.03.02.02, PAGE 30 FF., CHAPTER 2.4.8 MOVING THE PATIENT TABLE OR GANTRY) WARNING BOX: INCORRECT PATIENT POSITIONING, UNINTENDED PATIENT MOVEMENT, AND UNOBSERVED MOVEMENT OF THE PATIENT TABLE OR GANTRY! INJURY TO THE PATIENT, FOR EXAMPLE, CONTUSIONS OF THE PATIENT'S EXTREMITIES AND UNUSABLE RADIATION. ALWAYS FIX THE PATIENT WITH ACCESSORIES, AS DESCRIBED IN THE INSTRUCTIONS FOR USE, TO AVOID UNINTENTIONAL PATIENT MOVEMENT. FOR EXAMPLE, USE RESTRAINT STRAPS AND ARM SUPPORTS. MONITOR THE PATIENT CONTINUOUSLY AS LONG AS THE TABLETOP AND GANTRY ARE MOVING. TAKE SPECIAL CARE IF THE TILT OF THE GANTRY IS ANYTHING OTHER THAN ZERO DEGREES OR THE TABLE HEIGHT IS ANYTHING OTHER THAN THE ISOCENTER. MAKE SURE THAT NOTHING CAN GET CAUGHT WHILE THE TABLE OR GANTRY ARE MOVING. FOR EXAMPLE, PARTS OF THE BODY OR CLOTHING, ANY NEEDLES, INFUSION TUBES, RESPIRATION TUBES, CATHETERS, ECG CABLES, OR SHEETS AND BLANKETS. FOLLOW THE MARKINGS AND LABELS ON THE EQUIPMENT. PRESS A STOP KEY IF AN INJURY TO THE PATIENT CAN OCCUR.

    Description of Event or Problem · 0

    IT WAS REPORTED TO SIEMENS THAT AN ADVERSE EVENT OCCURRED WHILE OPERATING THE SOMATOM X.CITE CT SYSTEM. IT WAS REPORTED THAT A PATIENT'S (70 YEARS OLD, MALE) ARM WAS TRAPPED IN THE PATIENT TABLE ON (B)(6),2022. ACCORDING TO THE CUSTOMER, THE PATIENT WAS LYING HEAD FIRST AND FACE DOWN. AFTER THE SCAN, WHEN THE TABLE MOVED OUT, THE SKIN OF THE PATIENT'S ARM WAS PINCHED BETWEEN THE TABLE AND THE TABLE TOP. AN APPROXIMATELY 4-5 CM HEMATOMA FORMED, WHICH WAS TREATED WITH HYDROSALVE. NO OTHER INJURIES WERE REPORTED. THEREFORE, THIS REPORT HAS BEEN SUBMITTED WITH AN ABUNDANCE OF CAUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2503164 SOMATOM X.CITE SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED JAK SIEMENS HEALTHCARE GMBH-CT 11330001 04056869231044

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Other