BEUDAMED
    FDA Adverse Event Other Summary report: N

    DISPOSABLE LARYNGOSCOPE SYSTEM

    MDR report key: 39848 · Received September 5, 1996

    Report

    Report Number
    2020364-1996-00002
    Event Type
    Other
    Date Received
    September 5, 1996
    Date of Event
    August 2, 1996
    Report Date
    September 4, 1996
    Manufacturer
    ANESTHESIA MEDICAL SPECIALTIES
    Product Code
    EQN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN THE EMEREGENCY ROOM, A DISPOSABLE LARYNGOSCOPE BLADE (SIZE UNREPORTED)BROKE, NEAR THE CONTACT AREA, DURING AN INTUBATION ATTEMPT ON A 65 YEAR OLD FEMALE, WEIGHING APPROX 80 KILOS. THE PT WAS UNCONSCIOUS AND IN CARDIAC ARREST. ON A SECOND ATTEMPT, (TYPE OF BLADE USED IS UNKNOWN) THE PT WAS SUCCESSFULLY INTUBATED AND WAS STABILIZED. THE ATTENDING PHYSICIAN, STATED "INTUBATIONS ARE DIFFICULT AND TOO MUCH PRESSURE (FORCE) MAY HAVE BEEN USED". THE BLADE WAS NOT SAVED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISPOSABLE LARYNGOSCOPE SYSTEM LARYNGOSCOPE BLADE, DISPOSABLE EQN ANESTHESIA MEDICAL SPECIALTIES MACHINTOSH, SIZE UNKNOWN UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 65 * Other