BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEUVIZ 64 IN

    MDR report key: 9248671 · Received October 29, 2019

    Report

    Report Number
    3003575350-2019-00001
    Event Type
    Malfunction
    Date Received
    October 29, 2019
    Date of Event
    September 15, 2019
    Report Date
    October 19, 2019
    Manufacturer
    NEUSOFT MEDICAL SYSTEMS CO., LTD.
    Product Code
    JAK
    UDI-DI
    06970167440022
    PMA / PMN Number
    K121792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE STATEMENT OF THE EVENT BASED UPON CUSTOMER'S ADDRESS: "AN ELDERLY FEMALE PATIENT IN CRITICAL CONDITION DEPENDENT ON MECHANICAL VENTILATOR WITH CHEMICAL SEDATION WAS TAKEN TO THE RADIOLOGY DEPARTMENT TO PERFORM CHEST CT SCAN. PATIENT WAS PUT ON THE COUCH OF CT SCANNER, COVERED WITH A HOSPITAL SHEET AND WAS POSITIONED FEET FIRST. THE TECHNICIANS LEFT THE ROOM TO CARRY OUT THE DIAGNOSTIC STUDY. AT THE END OF THE SCAN PROCEDURE, THE TECHNICIANS OBSERVED THE PATIENT MOVING HER RIGHT LEG, THEY ENTERED QUICKLY THINKING THAT THE PATIENT HAD WOKEN UP. UPON ARRIVAL, THEY OBSERVED THAT THE GANTRY MYLAR RING HAD FALLEN, IT WAS FOUND OVER THE PATIENT'S LEGS. THE PATIENT SHOWED LACERATIONS IN THE RIGHT FOOT." AFTER THE EVENT, A NEW GANTRY MYLAR RING WAS INSTALLED AND THERE'S NO SIMILAR ISSUE WAS REPORTED FROM THIS SITE AGAIN. SINCE THE TECHNICIANS DIDN'T SEE HOW THE GANTRY MYLAR RING WAS FALLING AT THE TIME OF THE EVENT, THE PROCESS OF THE DISMOUNT OF THE GANTRY MYLAR RING COULD NOT BE DETERMINED EXACTLY. THE INVESTIGATION AND ANALYSIS BY NEUSOFT MEDICAL SYSTEMS CO., LTD. SUGGESTS TWO POSSIBILITIES FOR THIS EVENT: THE PATIENT WAS NOT PLACED IN THE MIDDLE OF THE COUCH, SO THE PATIENT'S RIGHT FOOT MIGHT HAS TOUCHED AND KICKED OFF THE GANTRY MYLAR RING DURING THE COUCH MOVEMENT AT THE TIME OF THE SCAN. THE PATIENT'S CLOTHING OR THE HOSPITAL SHEET MIGHT HAS RUBBED OFF THE MYLAR RING FROM THE GANTRY DURING THE COUCH MOVEMENT AT THE TIME OF THE SCAN. THOSE TWO CIRCUMSTANCES WOULD HAVE THE PATIENT SUFFERED THE LACERATIONS TO HER RIGHT FOOT BY THE EDGE OF THE GANTRY MYLAR RING. IN THE NEUVIZ 64 EN/IN USER MANUAL, THE TECHNICIANS ARE ASKED TO MAKE SURE THE PATIENT'S BODY OR RELATED STUFF SUCH AS CLOTHING OR HOSPITAL SHEET NOT GET CAUGHT IN THE DEVICE DURING POSITIONING AND SCANNING PROCESSES, THE TECHNICIANS SHOULD ALWAYS FOLLOWING THIS INSTRUCTION TO AVOID THIS KIND OF ACCIDENT.

    Description of Event or Problem · 0

    THE GANTRY MYLAR OF NEUVIZ 64IN CT SCANNER DISLODGED AND CONTACTED A PATIENT. PATIENT PRESENTED MODERATED LACERATIONS IN THE RIGHT FOOT. THE DOCTOR MADE X-RAYS TO THE PATIENT'S FOOT AND DID SKIN TREATMENT.

    Additional Manufacturer Narrative · 1

    NOTE: WE HAVE NOT RECEIVED THE DETAILED INFORMATION ON THE EVENT, SO WE CANNOT CONFIRM THE ACCURATE PROCESS HOW THE EVENT HAPPENED. WE SHALL FILE A FOLLOW-UP MDR TO CLARIFY THE EVENT DESCRIPTION. WE HAVE NOT COMPLETED OUR INVESTIGATION OF THIS EVENT, AND THEREFORE, WE CANNOT COMPLETE AT THIS TIME. WE SHALL FILE A FOLLOW-UP MDR AT THE COMPLETION OF THE INVESTIGATION. INTERNAL CROSS REFERENCE: COMPLAINT (B)(4). WE SUBMITTED A HARD COPY OF THE MDR REPORT ON THIS EVENT BY EXPRESS MAIL ON OCT 19, 2019. WE SUBMIT THIS EMDR REPORT BECAUSE OUR ELECTRONIC SUBMIT SYSTEM IS JUST READY.

    Description of Event or Problem · 1

    THE GANTRY MYLAR OF NEUVIZ 64IN CT SCANNER DISLODGED AND CONTACTED A PATIENT. PATIENT PRESENTED MODERATED LACERATIONS IN THE RIGHT FOOT. THE DOCTOR MADE X-RAYS TO THE PATIENT'S FOOT AND DID SKIN TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1048021 NEUVIZ 64 IN CT SCANNER JAK NEUSOFT MEDICAL SYSTEMS CO., LTD. NEUVIZ 64 IN 06970167440022

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other