BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MCGRATH MAC VIDEO LARYNGOSCOPE

    MDR report key: 12804243 · Received November 10, 2021

    Report

    Report Number
    MW5105279
    Event Type
    Injury
    Date Received
    November 10, 2021
    Date of Event
    November 1, 2021
    Report Date
    November 9, 2021
    Manufacturer
    AIRCRAFT MEDICAL LIMITED
    Product Code
    CCW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING A CARDIAC RESUSCITATION ON A PATIENT THAT WAS APNEIC, AN OROTRACHEAL INTUBATION WAS ATTEMPTED VIA USE OF THE MCGRATH MAC VIDEO LARYNGOSCOPE THREE TIMES. DURING ALL THREE ATTEMPTS, THE SCOPE POWERED OFF LOSING THE VIDEO CAPABILITIES AS WELL AS THE LIGHT ON THE BLADE THUS CAUSING THE INTUBATION ATTEMPT TO SECURE AN AIRWAY TO FAIL. THE SERIAL NUMBER OF SAID MCGRATH MAC VIDEO LARYNGOSCOPE IS (B)(4). THE PATIENT'S AIRWAY WAS ULTIMATELY SECURED VIA A BLS METHOD. THE BLADE WOULD POWER OFF THE VIDEO SCREEN AS WELL AS THE LIGHT. THIS POWER OFF OCCURRED 5 TIMES OUT OF 13 INTUBATION ATTEMPTS DURING THE IN HOUSE TESTING. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1683299 MCGRATH MAC VIDEO LARYNGOSCOPE LARYNGOSCOPE, RIGID CCW AIRCRAFT MEDICAL LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male Life Threatening