BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCGRATH

    MDR report key: 22383919 · Received July 2, 2025

    Report

    Report Number
    3010244187-2025-00566
    Event Type
    Malfunction
    Date Received
    July 2, 2025
    Report Date
    September 22, 2025
    Manufacturer
    AIRCRAFT MEDICAL LIMITED
    Product Code
    CCW
    UDI-DI
    15060272980020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D9, G3, H3, H6 H3 EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE WAS AVAILABLE FOR EVALUATION. VISUAL INSPECTION NOTED NORMAL WEAR AND TEAR ON THE RECEIVED VIDEO LARYNGOSCOPE AND BATTERY WITH NO SIGNIFICANT EXTERNAL DAMAGE. ATTEMPTS AT ACTIVATION RESULTED IN ONLY ILLUMINATION OF THE LED AND NO ACTIVATION OF THE DISPLAY. THE VIDEO LARYNGOSCOPE'S BATTERY WAS THEN REMOVED AND INSTALLED IN A KNOWN-GOOD VIDEO LARYNGOSCOPE (CL-16059) WHICH RESULTED IN THE SAME FAILURE DEMONSTRATED. TO FURTHER VERIFY, A KNOWN-GOOD BATTERY WAS INSTALLED IN THE VIDEO LARYNGOSCOPE UNDER INVESTIGATION WHICH RESULTED IN PROPER ACTIVATION OF THE DISPLAY ALONG WITH LED ILLUMINATION. THE BATTERY WAS THEN INSTALLED IN THE 10 SECOND BATTERY TEST BOX, WHERE NO MEASURED VOLTAGE OUTPUT WAS OBSERVED DURING THE TEST. IT WAS REPORTED THAT PRIOR TO USAGE, THE VIDEO LARYNGOSCOPE'S SCREEN DISPLAY WAS BLACK WITH NO IMAGE. THE LIGHT AT THE TIP OF THE BLADE WAS ON. ISSUE PERSIST EVEN SWAPPING WITH A NEW BATTERY. THE REPORTED ISSUE WAS CONFIRMED. THE MOST LIKELY CAUSE COULD NOT BE ESTABLISHED FROM THE INFORMATION AVAILABLE. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT MEETS ALL MEDTRONIC QUALITY SPECIFICATIONS. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USAGE, THE VIDEO LARYNGOSCOPE'S SCREEN DISPLAY WAS BLACK WITH NO IMAGE. THE LIGHT AT THE TIP OF THE BLADE WAS ON. ISSUE PERSIST EVEN SWAPPING WITH A NEW BATTERY. THERE WAS NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204663 MCGRATH LARYNGOSCOPE, RIGID CCW AIRCRAFT MEDICAL LIMITED 300-200-000 15060272980020

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown