BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIRTRAQ A-011

    MDR report key: 19942495 · Received August 7, 2024

    Report

    Report Number
    MW5158247
    Event Type
    Malfunction
    Date Received
    August 7, 2024
    Date of Event
    August 2, 2022
    Report Date
    August 5, 2024
    Manufacturer
    PRODOL MEDITEC LIMITED
    Product Code
    CCW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE LIGHT ON AN AIRTRAQ A-011 INTUBATION BLADE FAILED TO TURN ON, BOTH WHEN CONNECTED TO THE A-390 CAMERA AND WHEN INDEPENDENTLY TRIGGERED BY THE ORANGE ON/OFF BUTTON ON THE BLADE. THE BLADE WAS REMOVED FROM SEALED PACKAGING AT THE TIME OF USE. PATIENT WAS ALREADY IN CARDIAC ARREST WHEN UTILIZATION OF THIS BLADE WAS ATTEMPTED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED FOR REPORT MW5158247 ON 8/14/2024 FOR PROCODE CCW. THE LIGHT ON AN AIRTRAQ A-011 INTUBATION BLADE FAILED TO TURN ON, BOTH WHEN CONNECTED TO THE A-390 CAMERA AND WHEN INDEPENDENTLY TRIGGERED BY THE ORANGE ON/OFF BUTTON ON THE BLADE. THE BLADE WAS REMOVED FROM SEALED PACKAGING AT THE TIME OF USE.

    Description of Event or Problem · 0

    THE LIGHT ON AN AIRTRAQ A-011 INTUBATION BLADE FAILED TO TURN ON, BOTH WHEN CONNECTED TO THE A-390 CAMERA AND WHEN INDEPENDENTLY TRIGGERED BY THE ORANGE ON/OFF BUTTON ON THE BLADE. THE BLADE WAS REMOVED FROM SEALED PACKAGING AT THE TIME OF USE. PATIENT WAS ALREADY IN CARDIAC ARREST WHEN UTILIZATION OF THIS BLADE WAS ATTEMPTED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED FOR REPORT MW5158247 ON 8/14/2024 FOR PROCODE CCW. THE LIGHT ON AN AIRTRAQ A-011 INTUBATION BLADE FAILED TO TURN ON, BOTH WHEN CONNECTED TO THE A-390 CAMERA AND WHEN INDEPENDENTLY TRIGGERED BY THE ORANGE ON/OFF BUTTON ON THE BLADE. THE BLADE WAS REMOVED FROM SEALED PACKAGING AT THE TIME OF USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1935404 AIRTRAQ A-011 LARYNGOSCOPE, RIGID CCW PRODOL MEDITEC LIMITED A-011 I350702
    517603 AIRTRAQ A-011 LARYNGOSCOPE, RIGID CCW PRODOL MEDITEC LIMITED A-011 I350702

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male A-390| A-390
    1 65 YR Male A-390| A-390