BEUDAMED
    FDA Adverse Event Death Summary report: N

    MCGRATH LARYNGOSCOPE

    MDR report key: 12967451 · Received December 9, 2021

    Report

    Report Number
    3010244187-2021-00008
    Event Type
    Death
    Date Received
    December 9, 2021
    Date of Event
    November 1, 2021
    Report Date
    December 9, 2021
    Manufacturer
    AIRCRAFT MEDICAL LIMITED
    Product Code
    CCW
    PMA / PMN Number
    K882433
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER, THE DEVICE WAS BEING USED TO DELIVER PATIENT CARE FOR A PATIENT IN CARDIAC ARREST. UPON ATTEMPTING TO INTUBATE THE PATIENT, THE DISPLAY WENT BLANK AND THE LIGHT FAILED. THE DEVICE WAS WITHDRAWN FROM THE ORAL CAVITY AND WAS REPOWERED. THE DISPLAY CAME BACK ON ALONG WITH THE LIGHT. ATTEMPTS TO USE THE DEVICE AGAIN FAILED FOR A TOTAL OF 3 TIMES. AFTER THE FAILURES, THE PATIENT WAS NOT INTUBATED. A BLS AIRWAY WAS ESTABLISHED USING A KING AIRWAY. FURTHER TESTING REVEALED SIMILAR OUTCOMES. TWO OTHER BATTERIES WERE TESTED WITH THE DEVICE AND THE ISSUES CONTINUED. THE PATIENT EVENTUALLY EXPIRED. THE DEATH WAS NOT RELATED TO THE DEVICE FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1866526 MCGRATH LARYNGOSCOPE LARYNGOSCOPE, RIGID CCW AIRCRAFT MEDICAL LIMITED 300-200-000

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male Death| R