BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOMATOM FORCE

    MDR report key: 20987618 · Received December 20, 2024

    Report

    Report Number
    3004977335-2024-00154
    Event Type
    Injury
    Date Received
    December 20, 2024
    Date of Event
    December 19, 2024
    Report Date
    February 28, 2025
    Manufacturer
    SIEMENS HEALTHINEERS AG
    Product Code
    JAK
    PMA / PMN Number
    K230421
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B5: ADDITIONAL INFORMATION. H3, H6: SIEMENS HAS COMPLETED AN INVESTIGATION OF THE REPORTED EVENT. THE PATIENT'S FOOT SLIPPED OFF THE TABLE AND GOT CAUGHT BETWEEN THE TABLETOP AND THE GANTRY. THE PATIENT SHOULD BE FIXED AND OBSERVED AT ANY TIME ACCORDING TO THE INSTRUCTIONS FOR USE, CHAPTER "SAFETY INFORMATION"¿ DURING SYSTEM MOVEMENTS: 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. THE PLEXIRING WHICH WAS BROKEN WHEN COLLIDING WITH THE PATIENT'S FOOT WAS EXCHANGED AND THE WHOLE SYSTEM WAS CLEANED. AFTER A CHECKUP OF THE SYSTEM, IT WAS FULLY FUNCTIONAL AGAIN. SIEMENS ATTEMPTED AN INVESTIGATION OF THE BROKEN PLEXIRING; HOWEVER, IT WAS DISCARDED BY THE CUSTOMER AFTER THE EXCHANGE. THIS COMPLAINT HAS BEEN CLOSED. FURTHER ACTION IS NOT WARRANTED.

    Additional Manufacturer Narrative · 0

    SIEMENS IS CONDUCTING A THOROUGH INVESTIGATION OF THE REPORTED EVENT. AS THIS EVENT IS UNDER INVESTIGATION, A ROOT CAUSE HAS NOT YET BEEN DETERMINED. A SUPPLEMENT REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION. THE PATIENT IS DOING WELL OVERALL. THERE WAS A 15-20 MM WOUND AT THE BONY AREA OF THE ANKLE BUT NO INJURY TO THE BONE. THE WOUND WAS CLEANED AND STITCHED AFTER THE INCIDENT. THERE IS NO PERMANENT DAMAGE TO THE PATIENT'S HEALTH.

    Description of Event or Problem · 0

    IT WAS REPORTED TO SIEMENS THAT AN ADVERSE EVENT OCCURRED WHILE OPERATING THE SOMATOM FORCE CT SYSTEM. IT WAS REPORTED THAT A 48-YEAR-OLD MALE PATIENT WAS ON THE TABLE FOR A CT SCAN. THE PATIENT'S FOOT SLIPPED OFF THE TABLE BETWEEN THE TABLETOP AND GANTRY. THE PATIENT¿S FOOT WAS PRESSED AGAINST THE PLEX RING AND ENCOUNTERED ROTATING PARTS OF THE GANTRY. THIS CAUSED AN APPROX. 15-20 MM WOUND AT THE ANKLE. FURTHER DETAILS ABOUT THE INJURY, TREATMENT AND GENERAL PATIENT HEALTH STATUS ARE CURRENTLY NOT KNOWN. ADDITIONAL INFORMATION ABOUT THE PATIENTS¿ HEALTH STATUS AND INFORMATION FOR THE INVESTIGATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2061302 SOMATOM FORCE SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED JAK SIEMENS HEALTHINEERS AG 10742326

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Male Other