BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCGRATH

    MDR report key: 23499098 · Received November 7, 2025

    Report

    Report Number
    3003120897-2025-00522
    Event Type
    Malfunction
    Date Received
    November 7, 2025
    Date of Event
    November 3, 2025
    Report Date
    November 7, 2025
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    CCW
    UDI-DI
    10884521824157
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT PRODUCT: 340-000-000, 340-000-000 MCGRATH 3.6V BATTERY 340-000-000, LOT# H25051204. 340-000-000, 340-000-000 MCGRATH 3.6V BATTERY 340-000-000, LOT# H24122104. 340-000-000, 340-000-000 MCGRATH 3.6V BATTERY 340-000-000, LOT# H24071204. 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, IN AN AMBULANCE SETTING, MULTIPLE BATTERIES EXHIBITED SEVERAL ISSUES INCLUDING FAILURE TO TURN ON AND BLUE SCREENS APPEARING. HANDLES WERE TESTED WITH KNOWN GOOD BATTERIES, BUT IT WAS UNKNOWN IF THE PROBLEM WAS RESOLVED AFTER REPLACEMENT. FOR SOME DEVICES, THE LIGHT-EMITTING DIODE WAS ILLUMINATED ON THE DISPLAY, BUT THE BATTERY ICON WAS NOT SHOWN; FOR OTHERS, THE LED WAS NOT ILLUMINATED. THERE WAS NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1861954 MCGRATH LARYNGOSCOPE, RIGID CCW MEDTRONIC SOFAMOR DANEK USA, INC 340-000-000 H24071204 10884521824157

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown