BEUDAMED
    FDA Adverse Event Death Summary report: N

    MCGRATH LARYNGOSCOPE

    MDR report key: 7252816 · Received February 8, 2018

    Report

    Report Number
    3010244187-2018-00001
    Event Type
    Death
    Date Received
    February 8, 2018
    Date of Event
    January 23, 2018
    Report Date
    April 12, 2018
    Manufacturer
    AIRCRAFT MEDICAL LIMITED
    Product Code
    CCW
    PMA / PMN Number
    K882433
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY THE SAMPLE WAS RECEIVED FOR ANALYSIS AND THE REPORTED ISSUE OF THE DEVICE NOT ILLUMINATING WAS CONFIRMED. THE INVESTIGATION COULD NOT DETERMINE THE ROOT CAUSE OF THE EVENT. NO TREND HAS BEEN IDENTIFIED FOR THIS ISSUE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE DEVICE POWERED ON, BUT THE LIGHT ON THE HANDLE DID NOT COME ON. THE DISPLAY WAS VISIBLE WHEN VIEWED WITH SURROUNDING LIGHT. WHEN THEY ATTEMPTED TO INTUBATE THE PATIENT THEY COULD NOT SEE SINCE THE CAMERA LIGHT DID NOT ILLUMINATE. THEY USED A BACKUP MANUAL LARYNGOSCOPE TO INTUBATE THE PATIENT.

    Description of Event or Problem · 1

    THE DEVICE POWERED ON, BUT THE LIGHT ON THE HANDLE DID NOT COME ON. THE DISPLAY WAS VISIBLE WHEN VIEWED WITH SURROUNDING LIGHT. WHEN THEY ATTEMPTED TO INTUBATE THE PATIENT, THEY COULD NOT SEE SINCE THE CAMERA LIGHT DID NOT ILLUMINATE. THEY USED A BACKUP MANUAL LARYNGOSCOPE TO INTUBATE THE PATIENT. THE PATIENT IS DECEASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100407 MCGRATH LARYNGOSCOPE LARYNGOSCOPE, RIGID CCW AIRCRAFT MEDICAL LIMITED 300-200-000

    Patients

    Seq Age Sex Outcome Treatment
    1 Death