BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCGRATH

    MDR report key: 22388428 · Received July 2, 2025

    Report

    Report Number
    3010244187-2025-00568
    Event Type
    Malfunction
    Date Received
    July 2, 2025
    Date of Event
    June 30, 2025
    Report Date
    July 2, 2025
    Manufacturer
    AIRCRAFT MEDICAL LIMITED
    Product Code
    CCW
    UDI-DI
    10884521824157
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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 WHEN THE BATTERY WAS USED, THERE WAS NO DISPLAY. THE ISSUE OCCURRED IN A HOSPITAL SETTING. THE BATTERY THAT CAME WITH THE UNIT WAS REPLACED WITH A SPARE BATTERY, AFTER WHICH THE UNIT FUNCTIONED PROPERLY. THERE WAS NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612 MCGRATH LARYNGOSCOPE, RIGID CCW AIRCRAFT MEDICAL LIMITED 340-000-000 H23082604 10884521824157

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown