BEUDAMED
    FDA Adverse Event Death Summary report: N

    MCGRATH LARYNGOSCOPE

    MDR report key: 8039367 · Received November 5, 2018

    Report

    Report Number
    3010244187-2018-00002
    Event Type
    Death
    Date Received
    November 5, 2018
    Date of Event
    June 13, 2018
    Report Date
    December 7, 2018
    Manufacturer
    AIRCRAFT MEDICAL LIMITED
    Product Code
    CCW
    PMA / PMN Number
    K882433
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    (DATE OF DEATH). 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 INTUBATION, THE DEVICE'S BLADE CAME LOOSE BY DRAWING BACK THE DEVICE. IT WAS REPORTED THAT BLADE D IS CONNECTED FROM THE DEVICE AND REMAINED IN THROAT OF THE PATIENT. IT WAS STATED THAT DURING THE SECOND INTUBATION, THE SAME SITUATION WAS ACTUAL AND AGAIN THE BLADE CAME LOOSE. IT WAS REPORTED THAT AFTER INSPECTION OF THE BLADE, THE LIP FOR CONNECTION TO THE SCOPE WAS TOO FLEXIBLE. THE CUSTOMER REPORTED THAT THE PATIENT DIED BUT WAS NOT RELATED TO THE MALFUNCTION OF THE DEVICE.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING INTUBATION, THE DEVICE'S BLADE CAME LOOSE BY DRAWING BACK THE DEVICE. IT WAS REPORTED THAT BLADE DISCONNECTED FROM THE DEVICE AND REMAINED IN THE THROAT OF THE PATIENT. IT WAS STATED THAT DURING THE SECOND INTUBATION, THE SAME SITUATION WAS ACTUAL AND AGAIN THE BLADE CAME LOOSE. IT WAS REPORTED THAT AFTER INSPECTION OF THE BLADE, THE LIP FOR CONNECTION TO THE SCOPE WAS TOO FLEXIBLE. THE CUSTOMER REPORTED THAT THE PATIENT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    879373 MCGRATH LARYNGOSCOPE LARYNGOSCOPE, RIGID CCW AIRCRAFT MEDICAL LIMITED 350-071-000

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Death| R