BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCGRATH

    MDR report key: 21240713 · Received January 27, 2025

    Report

    Report Number
    3010244187-2025-00025
    Event Type
    Malfunction
    Date Received
    January 27, 2025
    Date of Event
    January 8, 2025
    Report Date
    January 27, 2025
    Manufacturer
    MEMPHIS RTG CONTRACT
    Product Code
    CCW
    UDI-DI
    10884521824157
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT PRODUCT: 340-000-000, MCGRATH 3.6V BATTERY 340-000-000, (LOT #: H23082404); 340-000-000, MCGRATH 3.6V BATTERY 340-000-000, (LOT #: H23082404); 340-000-000, MCGRATH 3.6V BATTERY 340-000-000, (LOT #: H23082404); 340-000-000, MCGRATH 3.6V BATTERY 340-000-000, (LOT #: H23082404) .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 PRIOR TO USE THE BATTERY DEVICE EXPERIENCED ISSUES AT A HOSPITAL, SPECIFICALLY WITH NO DISPLAY ON THE DEVICE AND THE BATTERY ICON NOT BEING DISPLAYED, ALTHOUGH THE LIGHT-EMITTING DIODE (LED) WAS ILLUMINATED. THERE WAS NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    780631 MCGRATH LARYNGOSCOPE, RIGID CCW MEMPHIS RTG CONTRACT 340-000-000 H23082404 10884521824157

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown