BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCGRATH

    MDR report key: 21415207 · Received February 19, 2025

    Report

    Report Number
    3010244187-2025-00064
    Event Type
    Malfunction
    Date Received
    February 19, 2025
    Date of Event
    October 2, 2023
    Report Date
    February 19, 2025
    Manufacturer
    AIRCRAFT MEDICAL LIMITED
    Product Code
    CCW
    UDI-DI
    15060272980068
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REGULATORY REPORT IS BEING SUBMITTED DUE TO RETROSPECTIVE REVIEW THROUGH CAPA 624392. D10 CONCOMITANT PRODUCTS: 340-000-000, MCGRATH 3.6V BATTERY 340-000-000 (LOT#:H21082004), 340-000-000, MCGRATH 3.6V BATTERY 340-000-000 (LOT#:H22081904), 340-000-000, MCGRATH 3.6V BATTERY 340-000-000 (LOT#:H22042504), 340-000-000, MCGRATH 3.6V BATTERY 340-000-000 (LOT#:H20121404), 340-000-000, MCGRATH 3.6V BATTERY 340-000-000 (LOT#:H21091104) H3 EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE WAS AVAILABLE FOR EVALUATION. FUNCTIONAL TESTING FOUND THAT THE CUSTOMER¿S BATTERY WAS THEN PUT INTO THE TEST, AND IT WAS FOUND THAT BOTH THE DISPLAY AND THE LIGHT EMITTING DIODE (LED) WOULD NOT WORK. IT WAS REPORTED THAT THE DEVICE WON'T TURN ON AND THE DISPLAY WAS BLANK. THE REPORTED ISSUES WERE CONFIRMED. THE MOST LIKELY CAUSE WAS TRACED TO COMPONENT FAILURE. 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

    ACCORDING TO THE REPORTER THE VIDEOLARYNGOSCOPE SHOWED FOUR SMALL SQUARES, AND THE SCREEN DID NOT APPEAR OR TURN ON WHEN THE BATTERY IN QUESTION WAS USED. THE BATTERY WAS REPLACED AND THE HANDLE WAS POWER CYCLED, BUT THE ISSUE REMAINED. THERE WAS NO PATIENT INVOLVEMENT. THE SIX ADDITIONAL BATTERIES SHOWED THE SAME FAILURE, AND IT WAS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT AT THE TIME OF THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1379779 MCGRATH LARYNGOSCOPE, RIGID CCW AIRCRAFT MEDICAL LIMITED 340-000-000 8068505 15060272980068

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SEE H11.