BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCGRATH

    MDR report key: 23679984 · Received December 1, 2025

    Report

    Report Number
    3010244187-2025-00580
    Event Type
    Malfunction
    Date Received
    December 1, 2025
    Date of Event
    November 13, 2025
    Report Date
    February 5, 2026
    Manufacturer
    AIRCRAFT MEDICAL LIMITED
    Product Code
    CCW
    UDI-DI
    10884521824157
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    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 THERE WAS A CONSIDERABLE TEAR AT THE PULL TAB AND TEARS AT THE BUTTON SURFACE. THE ONLY VISIBLE DEFECT THAT WAS FOUND WAS THE NEGATIVE CONTACT BEING BENT TOWARDS THE TOP OF THE HOUSING, WHICH WOULD SIGNIFICANTLY REDUCE PROPER ELECTRICAL CONTACT WITH ANY CONNECTED VIDEO LARYNGOSCOPE. FUNCTIONAL TESTING FOUND THAT WHEN THE BATTERY WAS THEN INSTALLED IN A TEST VIDEO LARYNGOSCOPE ALL ATTEMPTS AT ACTIVATION RESULTED NO OBSERVED SIGNS OF ACTIVATION, WHICH WAS ABNORMAL. NO ILLUMINATION OF THE DISPLAY NOR CAMERA LED WAS OBSERVED. IT WAS REPORTED THAT WHEN THE REPORTED BATTERY WAS INSERTED INTO THE VIDEO LARYNGOSCOPE, THE SCREEN DID NOT DISPLAY, AND THE PROBLEM WAS RESOLVED WITH ANOTHER BATTERY, BUT THE SCREEN DID NOT TURN ON EVEN WHEN TESTING ONLY THE BATTERY WITH ANOTHER VIDEO LARYNGOSCOPE. THE REPORTED ISSUE WAS CONFIRMED. THE MOST LIKELY CAUSE WAS TRACED TO COMPONENT FAILURE. 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 USE, WHEN THE REPORTED BATTERY WAS INSERTED INTO THE VIDEOLARYNGOSCOPE, THE SCREEN DID NOT DISPLAY, AND THE PROBLEM WAS RESOLVED WITH ANOTHER BATTERY, BUT THE SCREEN DID NOT TURN ON EVEN WHEN TESTING ONLY THE BATTERY WITH ANOTHER VIDEOLARYNGOSCOPE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2149271 MCGRATH LARYNGOSCOPE, RIGID CCW AIRCRAFT MEDICAL LIMITED 340-000-000 H24102504 10884521824157

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown