BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MCGRATH LARYNGOSCOPE

    MDR report key: 20289513 · Received September 24, 2024

    Report

    Report Number
    3010244187-2024-00017
    Event Type
    Injury
    Date Received
    September 24, 2024
    Date of Event
    September 6, 2024
    Report Date
    December 5, 2024
    Manufacturer
    AIRCRAFT MEDICAL LIMITED
    Product Code
    CCW
    PMA / PMN Number
    K882433
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D9, G3, H3, H6 H3 EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE WAS AVAILABLE FOR EVALUATION. THE EVALUATION FOUND NO POTENTIALLY CONTRIBUTING FACTORS, AND THE SAMPLE MET ALL RELATED SPECIFICATIONS. IT WAS REPORTED THAT THE VIDEOLARYNGOSCOPE HAD 100 MINUTES OF BATTERY LIFE, BUT IN THE COURSE OF PERFORMING AN INTUBATION ON A CARDIAC ARREST PATIENT, THE SCREEN SHUTS OFF. THE DEVICE WAS ABLE TO TURN BACK ON BUT WOULD IMMEDIATELY POWER CYCLE, THEN TURN OFF. THE PROVIDER MANAGING THE AIRWAY WAS UNABLE TO TRANSITION TO A DIRECT LARYNGOSCOPE, AS IT WAS LIKELY NOT GOING TO WORK BASED ON THE PATIENT¿S BODY BUILD. INSTEAD, A SUPRAGLOTTIC AIRWAY DEVICE WAS PLACED FOR AIRWAY MANAGEMENT. THE MOST LIKELY CAUSE COULD NOT BE IDENTIFIED BECAUSE NO RELATED PROBLEM WAS DETECTED WITH THE DEVICE. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT MEETS ALL MEDTRONIC QUALITY SPECIFICATIONS. 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, DURING USE, THE VIDEO LARYNGOSCOPE WAS POWERED ON WITH 100 MINUTES OF BATTERY LIFE. IN THE COURSE OF PERFORMING AN INTUBATION ON A CARDIAC ARREST THE SCREEN SHUT OFF, IT WAS ABLE TO BE TURNED BACK ON BUT WOULD IMMEDIATELY POWER CYCLE, THEN TURN BACK OFF. THE PROVIDER MANAGING THE AIRWAY WAS UNABLE TO TRANSITION TO A DIRECT LARYNGOSCOPE (DL) VIEW WITH THE VIDEO LARYNGOSCOPE WITH THE X3 BLADE, AND THE PATIENT¿S BODY HABITUS WAS SUCH THAT A DL VIEW WITH DL EQUIPMENT WAS LIKELY NOT GOING TO WORK, SO AN SUPRAGLOTTIC AIRWAY DEVICE WAS PLACED FOR AIRWAY MANAGEMENT. THERE WAS A DELAY IN MEDICAL CARE, BUT NO IMPACT TO THE PATIENT.

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER, THE VIDEOLARYNGOSCOPE HAD 100 MINUTES OF BATTERY LIFE, BUT IN THE COURSE OF PERFORMING AN INTUBATION ON A CARDIAC ARREST PATIENT, THE SCREEN SHUTS OFF. THE DEVICE WAS ABLE TO TURN BACK ON BUT WOULD IMMEDIATELY POWER CYCLE, THEN TURN OFF. THE PROVIDER MANAGING THE AIRWAY WAS UNABLE TO TRANSITION TO A DIRECT LARYNGOSCOPE, AS IT WAS LIKELY NOT GOING TO WORK BASED ON THE PATIENT¿S BODY BUILD. INSTEAD, A SUPRAGLOTTIC AIRWAY DEVICE WAS PLACED FOR AIRWAY MANAGEMENT. THERE WAS A DELAY IN MEDICAL CARE, BUT NO IMPACT ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1092123 MCGRATH LARYNGOSCOPE LARYNGOSCOPE, RIGID CCW AIRCRAFT MEDICAL LIMITED 300-200-000

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Male Required Intervention