BEUDAMED
    FDA Adverse Event Death Summary report: N

    MCGRATH MAC

    MDR report key: 20961065 · Received December 18, 2024

    Report

    Report Number
    3010244187-2024-00042
    Event Type
    Death
    Date Received
    December 18, 2024
    Date of Event
    November 21, 2024
    Report Date
    December 18, 2024
    Manufacturer
    PLEXUS ELECTRONICA S. DE R.L. DE C.V.
    Product Code
    CCW
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    D10 - CONCOMITANT PRODUCT: 340-000-000, MCGRATH 3.6V BATTERY 340-000-000, SERIAL# UNKNOWN. 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 CARDIAC ARREST FIELD INTUBATION, THE MCGRATH MAC VL HANDLE AND MCGRATH 3.6V BATTERY FAILED TO APPROPRIATELY TURN ON AND HAD NO DISPLAY. THE LED WAS ILLUMINATED ON THE DISPLAY. THE PATIENT DID NOT SURVIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274597 MCGRATH MAC LARYNGOSCOPE, RIGID CCW PLEXUS ELECTRONICA S. DE R.L. DE C.V. 301-000-000

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death SEE H11