BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MCGRATH LARYNGOSCOPE

    MDR report key: 17376062 · Received July 24, 2023

    Report

    Report Number
    3010244187-2023-00012
    Event Type
    Injury
    Date Received
    July 24, 2023
    Date of Event
    June 14, 2023
    Report Date
    July 28, 2023
    Manufacturer
    AIRCRAFT MEDICAL LIMITED
    Product Code
    CCW
    PMA / PMN Number
    K882433
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    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. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

    Additional Manufacturer Narrative · 0

    CORRECTION: B2, B5, H1, H6 THIS EVENT HAS BEEN REASSESSED AND THE REPORTABILITY HAS BEEN DETERMINED TO BE A SERIOUS INJURY. ADDITIONAL INFORMATION: D9, H3, H6 MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER, DURING A CRITICAL INCIDENT, THE VIDEO LARYNGOSCOPE HAD TWO WITNESSED FAILURES DURING AN ATTEMPTED INTUBATION. PARAMEDICS WERE ATTEMPTING INTUBATION DURING A PATIENT TRANSPORT AND THE VIDEO SCREEN SEEMED TO FADE OUT LIKE THE BATTERY DIED (BATTERY HAD 197 MINUTES ON IT INITIALLY, AFTER THE FAILURE, IT STATED IT HAD 167 MINUTES). DIRECT LARYNGOSCOPE WAS NEEDED TO FINISH THE INTUBATION. UPON ARRIVAL BACK AT THE STATION, THE PARAMEDICS WERE UNABLE TO REPLICATE THE FAILURE. THE PATIENT WAS EVENTUALLY DECEASED FROM THE HOSPITAL 2 DAYS AFTER BEING ADMITTED. AFTER SEVERAL DAYS THE HANDLE STILL DID NOT POWER ON AT ALL. SWAPPING WITH AN ALTERNATE BATTERY, HOWEVER, THE DEVICE DOES POWER ON AND SHOWS 250 MINUTES.

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER, DURING A CRITICAL INCIDENT, THE VIDEO LARYNGOSCOPE HAD TWO WITNESSED FAILURES DURING AN ATTEMPTED INTUBATION. PARAMEDICS WERE ATTEMPTING INTUBATION DURING A PATIENT TRANSPORT AND THE VIDEO SCREEN SEEMED TO FADE OUT LIKE THE BATTERY DIED. THE BATTERY HAD 197 MINUTES ON IT INITIALLY. AFTER THE FAILURE, IT STATED IT HAD 167 MINUTES. THE SAME ISSUE WAS EXPERIENCED DURING AN ATTEMPT BY ANOTHER PARAMEDIC TO USE THE DEVICE. DIRECT LARYNGOSCOPE WAS NEEDED TO FINISH THE INTUBATION. UPON ARRIVAL BACK AT THE STATION, THE PARAMEDICS WERE UNABLE TO REPLICATE THE ISSUE. THE PATIENT WAS EVENTUALLY DISCHARGED FROM THE HOSPITAL 2 DAYS AFTER BEING ADMITTED. AFTER SEVERAL DAYS THE HANDLE STILL DID NOT POWER ON AT ALL. HOWEVER, AFTER SWAPPING WITH AN ALTERNATE BATTERY, THE DEVICE DOES POWER ON AND SHOWS 250 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    771645 MCGRATH LARYNGOSCOPE LARYNGOSCOPE, RIGID CCW AIRCRAFT MEDICAL LIMITED 300-200-000

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Male Hospitalization| R| D SEE NOTE ON H10.