BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CANON

    MDR report key: 14185935 · Received April 22, 2022

    Report

    Report Number
    2020563-2022-00002
    Event Type
    Injury
    Date Received
    April 22, 2022
    Date of Event
    February 13, 2021
    Report Date
    April 22, 2022
    Manufacturer
    CANON MEDICAL SYSTEMS CORPORATION
    Product Code
    JAK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADVERSE EVENT TOOK PLACE ON (B)(6) 2021, DUE TO LEGAL ACTION BEING TAKEN BY PATIENT'S FAMILY, THIS INITIATED FURTHER INVESTIGATION INTO THE INCIDENT. THE ER DOCTOR STATED IN THEIR REPORT FROM 2021 THAT THE LACERATION OCCURRED ON A GURNEY. FURTHER INVESTIGATION IN RECENT WEEKS REVEALED THE EVENT OCCURRED IN/ON THE CT COUCH. IT WAS REPORTED PATIENT EXPIRED A FEW DAYS LATER AND THAT THE PATIENT WAS TRANSFERRED AND PASSED AWAY SOMEWHERE ELSE, THUS CAUSE OF DEATH IS UNKNOWN. FACILITY DOES STATE THE PATIENT'S PASSING WAS NOT A RESULT FROM THE LACERATION RECEIVED FROM THIS ADVERSE EVENT. BOTH THE RADIOLOGY DIRECTOR AND THE RISK MANAGEMENT OFFICER HAVE SINCE LEFT GREENWOOD LEFLORE HOSPITAL FOR NEW EMPLOYMENT AND NO FURTHER INFORMATION CAN BE OBTAINED. TO ENSURE SAFETY, PRECAUTIONS TO BE OBSERVED ARE PROVIDED IN THE OPERATION MANUAL. EXCERPT FROM THE OPERATION MANUAL 2B201-663EN, "BE SURE TO MOUNT THE COUCH ACCESSORIES SECURELY. OTHERWISE, THE ACCESSORIES MAY FALL, OR THE MOUNTING SECTIONS MAY BE DAMAGED, RESULTING IN PERSONAL INJURY. BE SURE TO USE THE COUCH ACCESSORIES CORRECTLY. OTHERWISE, PERSONAL INJURY OR DAMAGE TO THE SYSTEM MAY RESULT." IT WAS CONCLUDED THAT THE PHENOMENON WAS CAUSED BY "USER ERROR". THIS EVENT OCCURRED DUE TO LACK OF ATTENTION AND CARE WHEN REPOSITIONING PATIENT. AS A COUNTERMEASURE TO ENSURE FURTHER SAFETY, MANUFACTURE ANTICIPATES ISSUING A FIELD SERVICE INSTRUCTION (FSI) AROUND JUNE 2022. FSI WILL ASSERT CAUTION AND TO BEING EXTREMELY CAREFUL WHEN MOVING PATIENTS.

    Description of Event or Problem · 0

    PATIENT RECEIVED A LACERATION WHILE BEING REPOSITIONED FOR A CT SCAN. THE TECHNOLOGIST AND TRANSPORTER OF THE PATIENT TRANSFERRED THE PATIENT FROM THE STRETCHER TO THE CT COUCH. WHEN BEING REPOSITIONED UP THE COUCH INTO THE HEAD HOLDER FOR SCANNING, PATIENT'S HEAD HIT THE CARBON FIBER HEAD HOLDER RESULTING IN A LACERATION. PATIENT REQUIRED STITCHES. IT WAS REPORTED THAT THE PATIENT HAD AN ALTERED LEVEL OF CONSCIOUSNESS (ALOC) PRIOR TO THE ADVERSE EVENT. THERE WERE NO OTHER INJURIES OR SYMPTOMS REPORTED AFTER INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1732888 CANON SYSTEM, X-RAY TOMOGRAPHY COMPUTED JAK CANON MEDICAL SYSTEMS CORPORATION TSX-303A/5L

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other