BEUDAMED
    FDA Adverse Event Death Summary report: N

    MCGRATH MAC EMS HANDLE

    MDR report key: 21045029 · Received December 30, 2024

    Report

    Report Number
    3010244187-2024-00052
    Event Type
    Death
    Date Received
    December 30, 2024
    Date of Event
    April 16, 2024
    Report Date
    February 3, 2025
    Manufacturer
    AIRCRAFT MEDICAL LIMITED
    Product Code
    CCW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: B5 AND G3. 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.

    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 DURING PATIENT CARE, THE LIGHT WAS ON AT THE TIP OF THE SCOPE, BUT THE DISPLAY WAS BLANK. AS AN ALTERNATIVE, THE PATIENT WAS MANUALLY INTUBATED. DURING TROUBLESHOOTING, THE BATTERIES WERE SWAPPED WITHOUT SUCCESS, AND THE LIGHT BECAME INTERMITTENT. WHEN THE MANUAL LARYNGOSCOPY WAS PERFORMED, THE INITIAL PLACEMENT WAS INACCURATE AS IT WAS MISPLACED IN THE ESOPHAGUS AND A SUPRAGLOTTIC AIRWAY TECHNIQUE WAS THEN USED SUCCESSFULLY, BUT THE PATIENT EXPIRED IN THE FIELD. THE PATIENT WAS PULSELESS ON ARRIVAL FOR APPROXIMATELY 10 MINUTES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PATIENT CARE, THE LIGHT WAS ON AT THE TIP OF THE SCOPE, BUT THE DISPLAY WAS BLANK. AS AN ALTERNATIVE, THE PATIENT WAS MANUALLY INTUBATED. DURING TROUBLESHOOTING, THE BATTERIES WERE SWAPPED WITHOUT SUCCESS, AND THE LIGHT BECAME INTERMITTENT. WHEN THE MANUAL LARYNGOSCOPY WAS PERFORMED, THE INITIAL PLACEMENT WAS INACCURATE AND A SUPRAGLOTTIC AIRWAY TECHNIQUE WAS THEN USED SUCCESSFULLY, BUT THE PATIENT EXPIRED IN THE FIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1253302 MCGRATH MAC EMS HANDLE LARYNGOSCOPE, RIGID CCW AIRCRAFT MEDICAL LIMITED 300-200-000

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Unknown Death