BEUDAMED
    FDA Adverse Event Death Summary report: N

    MCGRATH MAC

    MDR report key: 20247425 · Received September 18, 2024

    Report

    Report Number
    3010244187-2024-00015
    Event Type
    Death
    Date Received
    September 18, 2024
    Date of Event
    August 11, 2024
    Report Date
    October 11, 2024
    Manufacturer
    AIRCRAFT MEDICAL LIMITED
    Product Code
    CCW
    UDI-DI
    15060272980020
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: A2, A3A, A4, A5B, B2, B5, B7, G3, H1, H6 (IME, IMF) THIS EVENT HAS BEEN REASSESSED AND THE REPORTABILITY HAS BEEN DETERMINED TO BE A DEATH. D10 CONCOMITANT PRODUCTS: 340-000-000, MCGRATH 3.6V BATTERY 340-000-000. 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

    ACCORDING TO THE REPORTER, PARAMEDICS WERE CARING FOR A CRITICAL PATIENT WITH AN ADMITTING DIAGNOSIS OF ASPHYXIATION DUE TO HANGING, INTENTIONAL SELF-HARM, AND CARDIAC ARREST. CPR AND MANUAL BAG VALVE MASK VENTILATION WERE ATTEMPTED. ENDOTRACHEAL INTUBATION WAS ATTEMPTED WITH THE DEVICE DURING CARDIAC ARREST. DURING USE, THE VIDEO LARYNGOSCOPE'S SCREEN WAS DESCRIBED AS BLURRING AND FADING IN AND OUT. THEY WERE ABLE TO SEE THEY HAD 94 MINUTES LEFT OF USE. THEN THERE WERE LINES ACROSS THE SCREEN AND IT WENT BLANK, BUT THE LED AT THE END REMAINED ILLUMINATED. WHEN DEVICE WAS NOT FUNCTIONAL, IT WAS TAKEN OUT OF SERVICE AND A SUPRAGLOTTIC AIRWAY WAS CONSIDERED. HOWEVER, DUE TO VOMITUS, THE PATIENT ENDED UP GETTING A SURGICAL CRICOTHYROTOMY ON SCENE TO SECURE THE AIRWAY. THE PATIENT HAD ROSC (RETURN OF SPONTANEOUS CIRCULATION) IN THE FIELD, BUT ULTIMATELY RE-ARRESTED AND DID NOT SURVIVE. AFTER 12 HOURS, THE DEVICE LIGHT WAS STILL ILLUMINATED. THE DEVICE WAS NOT TURNING OFF AND THE SCREEN WAS NOT TURNING ON BY CYCLING THE POWER. THE BATTERY WAS USED WITH TWO OTHER MCGRATH UNITS WITH THE ISSUE OCCURRED WITH THE BATTERY. THE BATTERY WAS REMOVED AND USED WITH THE ORIGINAL HANDLE AND THE DEVICE DID POWER UP, BUT THERE SEEMED TO BE SOME DIFFICULTY IN POWERING IT ON EVEN WITH A NEW BATTERY.

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER, DURING USE, THE VIDEO LARYNGOSCOPE'S SCREEN WAS DESCRIBED AS BLURRING AND FADING IN AND OUT. THEY WERE ABLE TO SEE THEY HAD 94 MINUTES LEFT OF USE. THEN THERE WERE LINES ACROSS THE SCREEN AND IT WENT BLANK, BUT THE LED AT THE END REMAINED ILLUMINATED. THE PATIENT ENDED UP GETTING A SURGICAL CRICOTHYROTOMY ON SCENE TO SECURE HIS AIRWAY. AFTER 12 HOURS, THE LIGHT WAS STILL ILLUMINATED AND WAS NOT TURNING OFF TO POWER CYCLE. REMOVED THE BATTERY AND USED TO ANOTHER HANDLE AND DID POWER UP. USED NEW BATTERY AND HAD TIMES DIFFICULTY POWERING ON. THERE WAS NO FURTHER HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1227264 MCGRATH MAC LARYNGOSCOPE, RIGID CCW AIRCRAFT MEDICAL LIMITED 300-000-000 15060272980020

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Male Required Intervention| D SEE H11.