BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONSOON III

    MDR report key: 9098474 · Received September 20, 2019

    Report

    Report Number
    8031033-2019-00008
    Event Type
    Malfunction
    Date Received
    September 20, 2019
    Date of Event
    April 23, 2019
    Report Date
    April 23, 2019
    Manufacturer
    ACUTRONIC MEDICAL SYSTEMS AG
    Product Code
    CBK
    PMA / PMN Number
    K012691
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANY ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER WILL BE INCLUDED IN A FOLLOW-UP REPORT. THE SUSPECT DEVICE WAS RETURNED FOR INVESTIGATION AND THE REPORTED ERRORS WERE REPRODUCIBLE. THE RESULTS OF THE ANALYSIS SHOWS THAT THE DEVICE IS WORKING PROPERLY AND NO DEVICE ISSUE WAS FOUND. THE TECHNICAL SUPPORT TEAM ATTRIBUTED THE REPORTED ISSUE TO INCORRECT OPERATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE POSITIVE END EXPIRATORY PRESSURE (PEEP) SENSOR ALARM WAS TRIGGERED ON THE DEVICE AND JET 2 WAS NOT WORKING. ADDITIONALLY, JET 2 TUBING WAS EXTREMELY HOT. THERE ARE SOME BUBBLES NEAR THE OUTLET OF THE JET 2 TUBING. THE CUSTOMER REPORTED THAT THE REPORTED ISSUE WAS DETECTED DURING CONFIGURATION AND THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    891526 MONSOON III VENTILATOR, CONTINUOUS, FACILITY USE CBK ACUTRONIC MEDICAL SYSTEMS AG MONSOON III + SHFJV UNIVERSAL UNIT +ETCO

    Patients

    Seq Age Sex Outcome Treatment
    1