BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOMATOM FORCE

    MDR report key: 19840174 · Received July 26, 2024

    Report

    Report Number
    3004977335-2024-00091
    Event Type
    Injury
    Date Received
    July 26, 2024
    Date of Event
    July 13, 2024
    Report Date
    July 26, 2024
    Manufacturer
    SIEMENS HEALTHCARE GMBH
    Product Code
    JAK
    UDI-DI
    04056869006956
    PMA / PMN Number
    K230421
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS HAS COMPLETED AN INVESTIGATION OF THE REPORTED EVENT. THE PATIENT DESTROYED THE PLEXIGLASS RING WITH HIS KNEE AND WAS NOT FIXED DURING THE EXAMINATION. THE PATIENT SHOULD BE FIXED AND OBSERVED AT ANY TIME ACCORDING TO THE INSTRUCTIONS FOR USE SOMATOM / SYNGO CT VB20 (PRINT NO. HC-C2-058.621.10.02.02, PAGE 90, CHAPTER 2.3.6 ¿ SAFETY INFORMATION ¿ DURING SYSTEM MOVEMENTS). CAUTION BOX: UNINTENTIONAL PATIENT MOVEMENT! INJURY TO THE PATIENT. ALWAYS FIX AND OBSERVE THE PATIENT DURING THE MEASUREMENT. SOMATOM / SYNGO CT VB20 (PRINT NO. HC-C2-058.621.10.02.02, PAGE 91, CHAPTER 2.3.6 ¿ 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 TABLE TOP 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. AS THERE IS NO SYSTEMATIC OR DESIGN ISSUE IDENTIFIED AND THE SYSTEM WORKS AS SPECIFIED, NO FURTHER MEASURES ARE DEEMED NECESSARY.

    Description of Event or Problem · 0

    IT WAS REPORTED TO SIEMENS THAT AN ADVERSE EVENT OCCURRED WHILE OPERATING THE SOMATOM FORCE CT SYSTEM. ON (B)(6) 2024, A PATIENT LIFTED HIS LEG WHILE SCANNING AND BROKE THE SEALING RING (SCAN WINDOW). THE PATIENT SUFFERED A SMALL ABRASION ON HIS LEG. THE MINIMAL ABRASION DID NOT REQUIRE MEDICAL INTERVENTION AND THE PATIENT WAS IN GOOD CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1735062 SOMATOM FORCE SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED JAK SIEMENS HEALTHCARE GMBH 10742326 04056869006956

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Male