BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANON

    MDR report key: 12569068 · Received October 4, 2021

    Report

    Report Number
    2020563-2021-00004
    Event Type
    Malfunction
    Date Received
    October 4, 2021
    Date of Event
    September 1, 2021
    Report Date
    December 10, 2021
    Manufacturer
    CANON MEDICAL SYSTEMS CORPORATION
    Product Code
    IYN
    UDI-DI
    04987670102509
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER ANALYZED LOG FILES FOR SYSTEM TO CONCLUDE THE FOLLOWING: THE PHENOMENON IS NOT A SYSTEM LOCK-UP BUT A FUNCTION RESTRICTION BY ERROR PROCESSING. THE ERROR "IMG_135" OCCURS BECAUSE OF THE RISE IN TEMPERATURE WITHIN THE TRANSDUCER WHEN LEAVING A TRANSDUCER IN THE SAME PLACE FOR AN EXTENDED PERIOD OF TIME. THE EQUIPMENT AND TRANSDUCER IS FUNCTIONING AS INTENDED AND WITHIN SPECIFICATION. MANUFACTURER CONFIRMED THE EQUIPMENT DISPLAYED AN ERROR DIALOG (IMG_135) AND THE CUSTOMER CLICKED THE [OK] BUTTON TO CLOSE THE DIALOG. THIS ERROR OCCURS WHEN THERE IS A RISE IN TEMPERATURE WITHIN THE TRANSDUCER. SYSTEM LOG FILES ALLOWS FOR THE DETECTION OF THE UNDESIRABLE STATE BY PROPERLY DISPLAYING THE ERROR DIALOG. BASED ON SYSTEM'S LOG FILE, ROUGHLY 40 MINUTES AFTER THE START OF USE THE TEMPERATURE REACHED THE UPPER LIMIT OF 40 DEGREES CELSIUS. AT THE TIME OF ERROR OCCURENCE, THE EQUIPMENT DISPLAYED THE ERROR DIALOG AND RESTRICTED SOME FUNCTIONS BY ERROR PROCESSING (TO AVOID LOW TEMPERATURE BURNS). THIS IS AN INTENDED REACTION. THE USER RESTARTED THE EQUIPMENT ACCORDING TO THE ERROR DIALOG AND THEN CONTINUED TO USE WITHOUT ANY FURTHER PROBLEMS OCCURRING. LOG ANALYSIS CONFIRMS THE EQUIPMENT AND TRANSDUCER IS FUNCTIONING AS INTENDED AND WITHIN SPECIFICATION.

    Additional Manufacturer Narrative · 0

    IT WAS ALSO REPORTED THAT THE SITE HAS RECORDED THIS AS A "NEAR-MISS INCIDENT" IN THEIR INTERNAL REPORTING SYSTEM. MANUFACTURER IS CURRENTLY INVESTIGATING INTO THE EVENT.

    Description of Event or Problem · 0

    DURING A PERICARDIOCENTESIS PROCEDURE AT PHELPS COUNTY REGIONAL MEDICAL CENTER ON (B)(6) 2021, IT WAS REPORTED THAT PSI-30BX TRANSDUCER STARTED TO MALFUNCTION AND EVENTUALLY THE ULTRASOUND SYSTEM BECAME UNRESPONSIVE. THE STAFF PERFORMED A HARD SHUT DOWN, RESULTING IN THE SUBSEQUENT BOOT UP TO TAKE OVER 4 MINUTES TO COMPLETE. DURING THIS TIME, PATIENT WAS STILL IN CRITICAL STAGE WITH THE NEEDLE STILL INSERTED IN THEIR CHEST CAVITY. AFTER THE BOOTUP COMPLETED, THE CUSTOMER WAS ABLE TO CONTINUE WITH THE PROCEDURE SUCCESSFULLY WITH NO PATIENT INJURY OCCURRING.

    Description of Event or Problem · 0

    DURING A PERICARDIOCENTESIS PROCEDURE AT (B)(6) REGIONAL MEDICAL CENTER ON (B)(6) 2021, IT WAS REPORTED THAT PSI-30BX TRANSDUCER STARTED TO MALFUNCTION AND EVENTUALLY THE ULTRASOUND SYSTEM BECAME UNRESPONSIVE. THE STAFF PERFORMED A HARD SHUT DOWN, RESULTING IN THE SUBSEQUENT BOOT UP TO TAKE OVER 4 MINUTES TO COMPLETE. DURING THIS TIME, PATIENT WAS STILL IN CRITICAL STAGE WITH THE NEEDLE STILL INSERTED IN THEIR CHEST CAVITY. AFTER THE BOOTUP COMPLETED, THE CUSTOMER WAS ABLE TO CONTINUE WITH THE PROCEDURE SUCCESSFULLY WITH NO PATIENT INJURY OCCURRING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1471219 CANON SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC IYN CANON MEDICAL SYSTEMS CORPORATION TUS-AI700/5N 04987670102509

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown