BEUDAMED
    FDA Adverse Event Death Summary report: N

    MCGRATH LARYNGOSCOPE

    MDR report key: 12597221 · Received October 8, 2021

    Report

    Report Number
    3010244187-2021-00005
    Event Type
    Death
    Date Received
    October 8, 2021
    Date of Event
    September 21, 2021
    Report Date
    November 16, 2021
    Manufacturer
    AIRCRAFT MEDICAL LIMITED
    Product Code
    CCW
    PMA / PMN Number
    K882433
    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, G3, H3, H6 H3 EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE WAS AVAILABLE FOR EVALUATION. THE EVALUATION FOUND THAT THE DISPLAY WOULD PRODUCE AN IMAGE, BUT IT WAS DISTORTED AND COULD NOT BE VIEWED WELL. THE BLADE DID NOT FIT CORRECTLY ON THE HANDLE. IT WAS REPORTED THAT THE DISPLAY WAS DEFECTIVE. THE REPORTED ISSUE WAS CONFIRMED. THE MOST LIKELY CAUSE WAS TRACED TO A COMPONENT FAILURE. IT WAS ALSO REPORTED THAT THE DISPLAY RECEIVED POWER BUT DID NOT DISPLAY AN IMAGE. THE REPORTED ISSUE COULD NOT BE CONFIRMED. THE MOST LIKELY CAUSE COULD NOT BE ESTABLISHED FROM THE INFORMATION AVAILABLE. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT MEETS ALL MEDTRONIC QUALITY SPECIFICATIONS. A SECONDARY REVIEW OF THE DEVICE HISTORY RECORDS FOUND NO POTENTIALLY CONTRIBUTING FACTORS. 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 CARDIAC ARREST, THE DEVICE SCREEN WENT FUZZY. THE DEVICE HAD A CLEAR SCREEN AND THE BATTERY SHOWED 145 MINUTES. WHEN THE BLADE WAS INSERTED, THE SCREEN WENT GRAINY AND THEN COMPLETELY BLACK. A SECOND BATTERY WAS TRIED, BUT THE SAME ISSUE WAS ENCOUNTERED. THERE WAS MARGINAL IMPACT TO PATIENT CARE AS THERE WAS A DELAY IN ESTABLISHING AN AIRWAY. THE HEALTH CARE PROFESSIONALS WERE ABLE TO CONTINUE VENTILATING THE PATIENT AND A VIDEO DEVICE WAS USED TO INTUBATE THE PATIENT. AFTER 30 MINUTES OF ATTEMPTED RESUSCITATION, THE PATIENT WAS PRONOUNCED DEAD. THE DEATH IS NOT RELATED TO THE DEVICE ISSUE.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING A CARDIAC ARREST, THE DEVICE SCREEN WENT FUZZY. THE DEVICE HAD A CLEAR SCREEN AND THE BATTERY SHOWED 145 MINUTES. WHEN THE BLADE WAS INSERTED, THE SCREEN WENT GRAINY AND THEN COMPLETELY BLACK. A SECOND BATTERY WAS TRIED, BUT THE SAME ISSUE WAS ENCOUNTERED. THERE WAS A DELAY IN ESTABLISHING AN AIRWAY.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING A CARDIAC ARREST, THE DEVICE SCREEN WENT FUZZY. THE DEVICE HAD A CLEAR SCREEN AND THE BATTERY SHOWED 145 MINUTES. WHEN THE BLADE WAS INSERTED, THE SCREEN WENT GRAINY AND THEN COMPLETELY BLACK. A SECOND BATTERY WAS TRIED BUT THE SAME ISSUE WAS ENCOUNTERED. THERE WAS A DELAY IN ESTABLISHING AN AIRWAY. AFTER 30 MINUTES OF ATTEMPTED RESUSCITATION, THE PATIENT WAS PRONOUNCED DEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1498589 MCGRATH LARYNGOSCOPE LARYNGOSCOPE, RIGID CCW AIRCRAFT MEDICAL LIMITED 300-200-000

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Unknown Other| D