BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CANON

    MDR report key: 12094865 · Received June 30, 2021

    Report

    Report Number
    2020563-2021-00002
    Event Type
    Injury
    Date Received
    June 30, 2021
    Date of Event
    June 14, 2021
    Report Date
    June 30, 2021
    Manufacturer
    CANON MEDICAL SYSTEMS CORPORATION
    Product Code
    LNH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER STATED THAT THIS INCIDENT OCCURED DURING TRAINING. CANON CUSTOMER ENGINEER CONFIRMED THAT THERE ARE WARNING SIGNS ON ENTRANCE DOOR OF MR SUITE CAUTIONING NOT TO ENTER SUITE WITH ANY FERROMAGNETIC MATERIALS, SPECIFICALLY CAUTIONING AGAINST ENTERING SUITE WITH FERROMAGNETIC WHEELCHAIRS. THIS INCIDENT IS ATTRIBUTED TO USER ERROR. IT WAS COMMUNICATED VERBALLY FROM CUSTOMER TO CUSTOMER ENGINEER THAT BEYOND THE AFOREMENTIONED STITCHES, THE INJURED PARTY HAS GONE TO DOCTOR AND THEN BACK TO HOSPITAL DUE TO CONTINUED SWELLING OF HIS SCROTUM. ACCORDING TO CUSTOMER AND CUSTOMER ENGINEER, IT IS PRESUMED THAT STAFF WERE AWARE THAT THE WHEELCHAIR WAS MAGNETIC, BUT PRESUMABLY, TO SAVE TIME, STAFF WOULD BRING WHEELCHAIR INTO THE ROOM TO THE FAR END OF THE COUCH TO TRANSFER PATIENTS RATHER THAN TAKE THE TIME TO TRANSFER THEM FROM THE MAGNETIC WHEELCHAIR TO NON-MAGNETIC WHEELCHAIR, AND THEN TO COUCH. AS OF JUNE 17TH, 2021, SYSTEM IS UP AND RUNNING ONCE AGAIN.

    Description of Event or Problem · 1

    CUSTOMER ALLEGED THAT MR TECH BECAME PINNED BETWEEN MAGNETIC WHEELCHAIR AND MAGNET. CUSTOMER NOTED THAT ANOTHER MR TECH QUENCHED THE MAGNET TO RESCUE THE PINNED TECH. CUSTOMER STATED THAT TECH WALKED TO THE ER ON HIS OWN, COMPLAINING OF PAIN IN ARM AND TESTICLES. TECH REPORTEDLY RECEIVED STITCHES IN HIS GROIN AREA AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    986647 CANON MAGNETIC RESONANCE IMAGING SYSTEM LNH CANON MEDICAL SYSTEMS CORPORATION MRT-1504/S4

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention