BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MCGRATH MAC

    MDR report key: 14316192 · Received May 7, 2022

    Report

    Report Number
    3010244187-2022-00002
    Event Type
    Injury
    Date Received
    May 7, 2022
    Date of Event
    February 23, 2022
    Report Date
    June 24, 2022
    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
    CO
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: B5, G1 (MFR CONTACT FIRST AND LAST NAME, EMAIL, PHONE), G3, H3, H6 H3 EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE WAS NOT RETURNED, BUT A PHOTO WAS AVAILABLE FOR EVALUATION. VISUAL INSPECTION NOTED THE PICTURE SHOWED DEVICE SAMPLE WITH DISTORTED SCREEN. IT WAS REPORTED THAT THE DISPLAY WAS DEFECTIVE. THE REPORTED ISSUE WAS 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, INTRA-OPERATIVELY, WHEN INDUCING ANESTHESIA, THE PATIENT PRESENTED WITH DIFFICULTY IN VENTILATION OVER A MASK. LARYNGOSCOPY WAS PERFORMED. NO VOCAL CORDS WERE VISUALIZED AND THE EPIGLOTTIS WAS VERY ANTERIOR AND UNSTABLE. VIDEO LARYNGOSCOPY WAS ATTEMPTED BUT INTUBATION WAS NOT POSSIBLE GIVEN THE IMPOSSIBILITY OF VISUALIZING THE STRUCTURES. A TONSILLECTOMY WAS PERFORMED AS A MEDICAL INTERVENTION.

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, WHEN INDUCING ANESTHESIA, THE PATIENT PRESENTED WITH DIFFICULTY IN VENTILATION OVER A MASK. LARYNGOSCOPY WAS PERFORMED. NO VOCAL CORDS WERE VISUALIZED AND THE EPIGLOTTIS WAS VERY ANTERIOR AND UNSTABLE. A TONSILLECTOMY WAS PERFORMED AS PATIENT WAS DIAGNOSIS WITH CHRONIC TONSILLITIS. VIDEO LARYNGOSCOPY WAS ATTEMPTED BUT INTUBATION WAS NOT POSSIBLE GIVEN THE IMPOSSIBILITY OF VISUALIZING THE STRUCTURES. THERE WAS GREAT DIFFICULTY AND IT WAS POSSIBLE TO INTUBATE THE PATIENT WITHOUT USING THE VIDEO LARONGOSCOPE AND ONCE INTUBATED, THE AIRWAY WAS PERMEABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1280859 MCGRATH MAC LARYNGOSCOPE, RIGID CCW AIRCRAFT MEDICAL LIMITED 300-000-000 15060272980020

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Male Required Intervention