BEUDAMED
    FDA Adverse Event Death Summary report: N

    MCGRATH

    MDR report key: 22394250 · Received July 3, 2025

    Report

    Report Number
    3010244187-2025-00569
    Event Type
    Death
    Date Received
    July 3, 2025
    Date of Event
    May 29, 2025
    Report Date
    July 3, 2025
    Manufacturer
    MEMPHIS RTG CONTRACT
    Product Code
    CCW
    UDI-DI
    10884521824157
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT PRODUCT: MCGRATH 3.6V BATTERY 340-000-000 LOT: H23051604. 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 DURING A PROCEDURE, TWO VIDEO LARYNGOSCOPE BATTERIES SHOWED INACCURATE REMAINING MINUTES AND THEN FLASHED BATTERY EMPTY SIGN. PATIENT WAS DECEASED DUE TO INJURIES, AND NOT ASSOCIATED WITH THE BATTERY FAILURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1176956 MCGRATH LARYNGOSCOPE, RIGID CCW MEMPHIS RTG CONTRACT 340-000-000 H23090304 10884521824157

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female Death SEE NOTES ON H11.