BEUDAMED
    FDA Adverse Event Death Summary report: N

    GLIDESCOPE CORE SMART CABLE

    MDR report key: 20273168 · Received September 20, 2024

    Report

    Report Number
    9615393-2024-00120
    Event Type
    Death
    Date Received
    September 20, 2024
    Date of Event
    August 21, 2024
    Report Date
    August 22, 2024
    Manufacturer
    VERATHON MEDICAL ULC
    Product Code
    CCW
    UDI-DI
    00879123006752
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED GLIDESCOPE CORE SMART CABLE WAS RETURNED TO VERATHON FOR EVALUATION ALONG WITH THE GLIDESCOPE CORE 10-INCH MONITOR (SERIAL NUMBER: (B)(6) USED DURING THE REPORTED EVENT. A VERATHON TECHNICAL SERVICE REPRESENTATIVE EVALUATED THE RETURNED DEVICES AND WAS ABLE TO CONFIRM THE REPORTED FAILURE. PARTIAL PLASTIC WAS MISSING FROM THE HDMI CONNECTOR HOUSING AND TWO (2) HDMI PINS WERE DAMAGED. WHEN CONNECTING THE SMART CABLE TO VERATHON'S TEST EQUIPMENT, IT PRODUCED AN INTERMITTENT IMAGE. THE CUSTOMER'S SMART CABLE FAILED VERATHON'S DEVICE FUNCTIONALITY TESTING. THE CUSTOMER'S RETURNED MONITOR PASSED VISUAL INSPECTION AND VERATHON'S DEVICE FUNCTIONALITY TESTING. WHEN CONNECTED TO VERATHON'S TEST EQUIPMENT, IT PRODUCED A NORMAL IMAGE AND WAS CONFIRMED TO BE FUNCTIONING AS INTENDED. UPON COMPLETION OF VERATHON'S DEVICE EVALUATION, A REPLACEMENT GLIDESCOPE CORE SMART CABLE WAS PROVIDED TO THE CUSTOMER ALONG WITH RETURNING THEIR MONITOR THAT WAS EVALUATED. THE LARYNGOSCOPE USED WITH THE SMART CABLE DURING THE REPORTED EVENT WAS NOT MADE AVAILABLE TO VERATHON FOR EVALUATION. WHILE THE PATIENT INVOLVED IN THIS EVENT ENDED UP PASSING AWAY, THEY WERE REPORTED TO BE EXPERIENCING A CARDIAC ARREST AND THEREFORE NEEDING TO BE INTUBATED. THE FACILITY REPORTED THAT THE PATIENT DEATH DID NOT OCCUR DURING THE INTUBATION PROCEDURE ITSELF. THE FACILITY DID NOT REPORT THAT THE DEVICE MALFUNCTION CAUSED OR CONTRIBUTED TO THE CARDIAC ARREST NOR TO THE PATIENT'S DEATH. VERATHON HAS NOT RECEIVED ANY REPORTS ALLEGING PATIENT OR USER HARM AS A RESULT OF THIS FAILURE MODE. VERATHON WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED WHILE USING A GLIDESCOPE CORE SMART CABLE DURING INTUBATION OF A PATIENT EXPERIENCING CARDIAC ARREST, THE VIDEO FLICKERED IN AND OUT. IT WAS REPORTED THAT THE PATIENT ENDED UP PASSING AWAY. THE FACILITY REPORTED THAT THE PATIENT DEATH DID NOT OCCUR DURING THE INTUBATION PROCEDURE ITSELF. FOLLOW-UP INFORMATION RECEIVED FROM THE FACILITY'S PATIENT CARE MANAGER REPORTED THAT THEY WERE NOT ABLE TO COMPLETE THE PROCEDURE WITH THE ORIGINAL DEVICE. THE PROCEDURE WAS DELAYED APPROXIMATELY THREE (3) MINUTES. IT WAS REPORTED THAT A GLIDESCOPE SPECTRUM SINGLE-USE S3 LARYNGOSCOPE (UNKNOWN MODEL AND LOT NUMBER) WAS CONNECTED TO THE ORIGINAL GLIDESCOPE CORE SYSTEM FOR THE PROCEDURE. THE FACILITY DECLINED TO PROVIDE ANY FURTHER INFORMATION ABOUT THE PATIENT INVOLVED OR WHETHER THEY WERE ABLE TO SUCCESSFULLY COMPLETE THE PROCEDURE USING A BACKUP DEVICE "DUE TO HIPAA REASONS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1404813 GLIDESCOPE CORE SMART CABLE LARYNGOSCOPE, RIGID CCW VERATHON MEDICAL ULC 0600-0783 N/A 00879123006752

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death