BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOMATOM DRIVE

    MDR report key: 15474579 · Received September 23, 2022

    Report

    Report Number
    3004977335-2022-44856
    Event Type
    Injury
    Date Received
    September 23, 2022
    Date of Event
    September 14, 2022
    Report Date
    September 22, 2022
    Manufacturer
    SIEMENS HEALTHCARE GMBH-CT
    Product Code
    JAK
    UDI-DI
    04056869006970
    PMA / PMN Number
    K190578
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS HAS COMPLETED AN INVESTIGATION OF THE REPORTED EVENT. THE ROOT CAUSE WAS DETERMINED TO BE A HANDLING ERROR. THE PATIENT SHOULD BE FIXED ACCORDING TO THE INSTRUCTIONS FOR USE (PRINT NO. (B)(4), PAGE 65, CHAPTER 2.3 SAFETY INFORMATION ON PATIENT TRANSPORT AND POSITIONING). 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. CAUTION BOX: INCORRECT PATIENT POSITIONING! INJURY TO THE PATIENT OR PERSONNEL, AND DAMAGE TO THE EQUIPMENT. ALWAYS VERIFY THAT THE PATIENT IS CORRECTLY POSITIONED. ALWAYS OBSERVE THE PATIENT DURING SYSTEM MOVEMENTS.

    Description of Event or Problem · 0

    IT WAS REPORTED TO SIEMENS THAT AN ADVERSE EVENT OCCURRED WHILE OPERATING THE SOMATOM DRIVE CT SYSTEM. IT WAS REPORTED THAT A PATIENT BROKE THROUGH THE CT GANTRY PLEXI-RING (SCAN WINDOW) WITH HIS KNEE DURING AN EXAMINATION ON (B)(6) 2022. THE HOSPITAL DID NOT USE ANY STRAPS TO PREVENT THE PATIENT FROM MOVING AS THE PATIENT WAS IN A GREAT AMOUNT OF PAIN. DURING THE SCAN, THE PATIENT EXPERIENCED DISTRESS AND KICKED HIS KNEE INTO THE PLEXI-RING, BREAKING THROUGH THE PLEXI-RING AND MEETING THE ROTATING PART OF THE GANTRY. THE PATIENT WAS IMMEDIATELY SENT TO THE EMERGENCY DEPARTMENT FOR EVALUATION AND RECEIVED STITCHES IN THE KNEE BEFORE BEING SENT HOME. WE ARE UNAWARE OF ANY FURHTER IMPACT TO THE STATE OF HEALTH OF THE PATIENT INVOLVED. THERE WAS NO DEVICE MALFUNCTION REPORTED. THEREFORE, THIS REPORT HAS BEEN SUBMITTED WITH AN ABUNDANCE OF CAUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568365 SOMATOM DRIVE SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED JAK SIEMENS HEALTHCARE GMBH-CT 10431700 04056869006970

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention