BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Tube mount, x-ray, diagnostic

    MDR report key: 24451658 · Received February 26, 2026

    Report

    Report Number
    3005920099-2006-00001
    Event Type
    Malfunction
    Date Received
    February 26, 2026
    Date of Event
    November 11, 2025
    Report Date
    November 22, 2025
    Manufacturer
    SHINYOUNG FOR M CO., LTD.
    Product Code
    IYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6) (INITIAL REPORTER) SENT INFORMATION OF THE INCIDENT TO THE (B)(6), OFFICIAL CORRESPONDENT FOR SYFM (US, MANUFACTURER). THE WARRANTY AGREEMENT FOR THE UNIT ENDED ON (B)(6) 2012 AND HAS NOT SINCE BEEN SERVICED BY (B)(6). ON THE DAY OF THE ADVERSE EVENT, THE CLINIC CALLED (B)(6) TECHNICAL SUPPORT TO REPORT THE INCIDENT. THE FIELD SERVICE ENGINEER ((B)(6), TECHNICAL SUPPORT FOR (B)(6)) WAS DISPATCHED TO THE FACILITY AND VERIFIED THAT THE X-RAY TUBE WAS CALIBRATED TO STOP 12 INCHES ABOVE THE TABLE. HE DID NOT IDENTIFY ANY ISSUES AND CONFIRMED THE SYSTEM WAS FUNCTIONING PROPERLY. HE REPORTED THAT THE XRAY SYSTEM IS STILL IN USE AT THE CLINIC.

    Description of Event or Problem · 0

    AS REPORTED BY THE CLINIC AT WHICH THE INCIDENT OCCURRED, PATIENT WAS LYING SUPINE ON A TABLE TO HAVE IMAGING PERFORMED, A LEFT AXILLARY VIEW SHOULDER. THE MOTORIZED X-RAY TUBE WAS COMMANDED TO DRIVE DOWN VERTICALLY BY THE RADIOLOGY TECHNOLOGIST. THE TECHNOLOGIST CEASED PUSHING THE BUTTON BUT THE X-RAY TUBE CONTINUED TO DRIVE DOWN. THE X-RAY TUBE IMPACTED THE PATIENT'S LEFT KNEE AND LOCKED. THE TECHNOLOGIST DID NOT USE THE EMERGENCY STOP BUTTON AND DID NOT LOWER THE TABLE TO FREE THE PATIENT. THE PATIENT'S KNEE WAS REMOVED FROM BETWEEN THE TABLE AND THE X-RAY TUBE. THE PATIENT RECEIVED FIRST AID CARE IMMEDIATELY. THE PATIENT WAS ABLE TO AMBULATE TO THEIR CAR FOLLOWING THE INCIDENT. THE CLINIC WAS CONTACTED ON EIGHT OCCASIONS AND DECLINED TO SHARE INFORMATION ABOUT THE CURRENT STATUS OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    627956 Tube mount, x-ray, diagnostic IYB SHINYOUNG FOR M CO., LTD. SC-1001

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Female Other