BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLIDESCOPE CORE 15-INCH MONITOR

    MDR report key: 12002853 · Received June 15, 2021

    Report

    Report Number
    9615393-2021-00190
    Event Type
    Malfunction
    Date Received
    June 15, 2021
    Date of Event
    June 4, 2021
    Report Date
    June 4, 2021
    Manufacturer
    VERATHON MEDICAL ULC
    Product Code
    CCW
    UDI-DI
    00879123006400
    PMA / PMN Number
    K191948
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE GLIDESCOPE CORE 15-INCH MONITOR WAS RETURNED TO VERATHON FOR EVALUATION. A VERATHON ENGINEER EVALUATED THE RETURNED DEVICE AND WAS ABLE TO REPRODUCE THE REPORTED "DARK IMAGE" ISSUE. DUE TO THE EXTENSIVE TESTING DONE TO THIS DEVICE TO INVESTIGATE THE FOLLOWING ISSUE, VERATHON HAS PROACTIVELY DECIDED TO REPLACE THE CUSTOMER'S GLIDESCOPE CORE 15-INCH MONITOR WITH ANOTHER. UPON COMPLETION OF VERATHON'S INVESTIGATION A REPLACEMENT GLIDESCOPE CORE 15-INCH MONITOR WAS SENT TO THE CUSTOMER. VERATHON HAS COMPLETED ITS INVESTIGATION OF THE REPORTED DARK IMAGE ISSUE FOR THE COMBINATION OF THE GLIDESCOPE 15-INCH MONITOR IN CONJUNCTION WITH A GLIDESCOPE BFLEX SINGLE-USE BRONCHOSCOPE IN CAPA-2021-0003. MEASUREMENTS OF THE ANALOG VIDEO SIGNAL WERE TAKEN WHEN A DARK IMAGE WAS DISPLAYED. THE ANALOG VIDEO CLOCK SIGNAL TIMING WAS OBSERVED TO BE DELAYED, RESULTING IN THE TRANSMISSION OF THE DARK IMAGE. A DESIGN REVIEW WAS CONDUCTED, THE DELAY WAS DETERMINED TO BE RESULT OF TWO RESISTOR SETS IN THE BFLEX RECEPTACLE. IMPROVING ONE OR BOTH RESISTOR SETS WAS SHOWN TO REDUCE OR ELIMINATE THE INSTANCES OF DARK IMAGE. VERIFICATION SAMPLES WERE PRODUCED WITH THE COMPONENT IMPROVEMENTS MADE ON THE BFLEX RECEPTACLE, DESIGN VERIFICATION WAS COMPLETED, AND AN ENGINEERING CHANGE ORDER (ECO) WAS RELEASED TO IMPLEMENT THE CHANGES. AS PART OF THE INVESTIGATION A POST LAUNCH RISK ASSESSMENT (PLRA) WAS PERFORMED. THE PLRA DETERMINED THAT THE OBSERVED SEVERITY AND PROBABILITY OF OCCURRENCE FOR THIS FAILURE MODE WERE IN ALIGNMENT WITH THE PREDICTED SEVERITY AND PROBABILITY OF OCCURRENCE. DURING THE PLRA, COMPLAINT DATA WAS REVIEWED. IN ALL INSTANCES THE USER COMPLETED AN UNPLUG/PLUG SEQUENCE TO RESTORE FUNCTIONALITY OR SWITCHED TO A BACKUP DEVICE TO COMPLETE THE PROCEDURE. NO ADVERSE EVENTS WERE REPORTED. BASED ON THIS REVIEW OF THE SYSTEM RISK ASSESSMENT AND THE COMPLAINT DATA NO ADDITIONAL ACTION IS REQUIRED, VERATHON WILL CONTINUE TO MONITOR FOR TRENDS. ALL FORWARD PRODUCTION INCORPORATES THIS CHANGE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT DURING AN EMERGENCY CARE PROCEDURE, USING A GLIDESCOPE CORE 15-INCH MONITOR WITH A GLIDESCOPE BFLEX 5.8 BRONCHOSCOPE, THE IMAGE ON THE SCREEN BLACKED OUT. NO DELAY IN THE PROCEDURE, USE OF A BACKUP DEVICE, OR HARM TO THE PATIENT OR USER WAS REPORTED.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DECLINED TO HAVE THEIR GLIDESCOPE BFLEX 5.8 BRONCHOSCOPE RETURNED TO VERATHON FOR EVALUATION. THE COMPLAINT HISTORY RECORD FOR THE LOT NUMBER FT210400 WAS REVIEWED WITH ONLY ONE (1) ADDITIONAL COMPLAINT RELATED TO THIS LOT NUMBER ENCOUNTERED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED IN ACCORDANCE WITH 21 CFR 803.56. CORRECTIVE ACTION IS NOT REQUIRED AT THIS TIME. VERATHON WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING AN EMERGENCY CARE PROCEDURE, USING A GLIDESCOPE BFLEX 5.8 BRONCHOSCOPE, THE IMAGE ON THE SCREEN BLACKED OUT. NO DELAY IN THE PROCEDURE, USE OF A BACKUP DEVICE, OR HARM TO THE PATIENT OR USER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    898660 GLIDESCOPE CORE 15-INCH MONITOR LARYNGOSCOPE, RIGID CCW VERATHON MEDICAL ULC 0570-0404 N/A 00879123006400
    898661 GLIDESCOPE CORE 15-INCH MONITOR LARYNGOSCOPE, RIGID CCW VERATHON MEDICAL ULC 0570-0404 N/A 00879123006400

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown