BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONSOON III

    MDR report key: 6916591 · Received October 5, 2017

    Report

    Report Number
    8031033-2017-00006
    Event Type
    Malfunction
    Date Received
    October 5, 2017
    Date of Event
    September 6, 2017
    Report Date
    October 23, 2017
    Manufacturer
    ACUTRONIC MEDICAL SYSTEMS AG
    Product Code
    CBK
    PMA / PMN Number
    K012691
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DESCRIPTION OF THE HEALTH PROFESSIONAL: (B)(6). DEAR (B)(6), THE PATIENT WAS PREGNANT AND AFTER GAS INDUCTION OF ANAESTHESIA, HER BREATHING BECAME LABOURED AND HER AIRWAY OBSTRUCTED. AT THIS POINT, THE MONSOON WAS TO HAVE BEEN USED TO OXYGENATE THE PATIENT. THE JET VENTILATION SHOULD HAVE HELP OXYGENATE THE PATIENT AND ALSO OPEN UP THE UPPER AIRWAY TO HELP FACILITATE INTUBATION. AS SOON AS THE MONSOON FAILED, WE TRIED A FEW TIMES TO MAKE IT WORK BY PRESSING THE START BUTTON ON AND OFF A FEW TIMES. BUT IT WOULDN'T WORK. IT PROBABLY TOOK LESS THAN A MINUTE TO SET UP THE RAPID O2 AND CONNECT TO THE CRICOTHYROIDOTOMY NEEDLE AND THEN INSUFFLATE. THE PATIENT DESATURATED AND BECAME HYPOXIC WITH LOWEST SPO2 63% BEFORE RISING TO 100% AFTER USING THE RAPID O2. THE PATIENT RECOVERED WELL AFTER THE OPERATION; HER FETUS WAS MONITORED AND NO APPARENT ILL EFFECTS WERE DETECTED AT THE TIME. MY DEFAULT IT SETTING IS USUALLY 30%. (B)(6).

    Description of Event or Problem · 1

    (B)(6). THE PATIENT WAS PREGNANT AND AFTER GAS INDUCTION OF ANAESTHESIA, HER BREATHING BECAME LABOURED AND HER AIRWAY OBSTRUCTED. AT THIS POINT, THE MONSOON WAS TO HAVE BEEN USED TO OXYGENATE THE PATIENT. THE JET VENTILATION SHOULD HAVE HELP OXYGENATE THE PATIENT AND ALSO OPEN UP THE UPPER AIRWAY TO HELP FACILITATE INTUBATION. AS SOON AS THE MONSOON FAILED, WE TRIED A FEW TIMES TO MAKE IT WORK BY PRESSING THE START BUTTON ON AND OFF A FEW TIMES. BUT IT WOULDN'T WORK. IT PROBABLY TOOK LESS THAN A MINUTE TO SET UP THE RAPID O2 AND CONNECT TO THE CRICOTHYROIDOTOMY NEEDLE AND THEN INSUFFLATE. THE PATIENT DESATURATED AND BECAME HYPOXIC WITH LOWEST SPO2 63% BEFORE RISING TO 100% AFTER USING THE RAPID O2. THE PATIENT RECOVERED WELL AFTER THE OPERATION; HER FETUS WAS MONITORED AND NO APPARENT ILL EFFECTS WERE DETECTED AT THE TIME. MY DEFAULT IT SETTING IS USUALLY 30%. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696215 MONSOON III MONSOON III CBK ACUTRONIC MEDICAL SYSTEMS AG 212001

    Patients

    Seq Age Sex Outcome Treatment
    1