BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEBULAE I

    MDR report key: 21725019 · Received March 28, 2025

    Report

    Report Number
    0001450997-2025-00002
    Event Type
    Malfunction
    Date Received
    March 28, 2025
    Date of Event
    February 2, 2025
    Report Date
    March 28, 2025
    Manufacturer
    NORTHGATE TECHNOLOGIES INC.
    Product Code
    HIF
    UDI-DI
    00817183020189
    PMA / PMN Number
    K120151
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON 02/27/2025 NORTHGATE TECHNOLOGIES, INC WAS MADE AWARE OF THE ALLEGED EVENT, " DURING USE, OVERPRESSURIZATION OCCURRED, CAUSING THE LID OF THE WRAP DISK TO FLY OFF, AND THE PATIENT'S STOMACH TO SWELL. THE PATIENT'S VITAL SIGNS ALSO TEMPORARILY DROPPED BUT RECOVERED AND NO ADDITIONAL TREATMENT WAS REQUIRED." THE DEVICE WAS RETURNED AND EVALUATED ON 3/18/2025. THE UNIT WAS EVALUATED AND THE DEVICE PERFORMED AS EXPECTED AND DESIGN WHEN TESTED BY SERVICE AND ENGINEERING. THE UNIT WAS NOT FOUND TO BE CAPABLE OF EXCEEDING 3MMHG OF PRESSURE OVER THE SET POINT ON ITS OWN DURING ALL TESTING (INCLUDING A SIMULATED USE WITH THE DETAILS KNOWN BY NTI REGARDING THE COMPLAINT EVENT). ALL OF THE DEVICE SAFETY FEATURES WERE OPERATING AS DESIGNED AND EXPECTED IN THE DEVICE. THE COMPLAINT ISSUE WAS NOT DUE TO A MALFUNCTION OF THE DEVICE AND WAS MOST LIKELY CAUSED BY A COMBINATION OF FACTORS DURING THE SURGERY THAT LEAD TO A BRIEF SPIKE IN PRESSURE AS NOTED IN THE COMPLAINT (NTI IS AWAITING FURTHER DETAILS AROUND WHAT WAS OCCURING IN THE SURGERY WHEN THE EVENT OCCURED). THE DEVICE HISTORY RECORD FOR 92785DCF FROM APRIL OF 2018 (MO 13163) WAS REVIEWED AND THE DEVICE FAILED FIRST CALIBRATION ATTEMPT DUE TO DEVICE ISSUING FAULT CODE 17, THE ISSUE WAS TRACED TO THE VALVE BOARD. AFTER REPLACING THE VALVE BOARD, THE DEVICE WAS CALIBRATED SUCCESSFULLY AND PASSED ALL FQC TESTING. THE DEVICE HAS NOT BEEN RETURNED TO NTI FOR REPAIR / EVALUATION PREVIOUSLY. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED TO NTI FOR THIS DEVICE. (B)(4) RISK ANALYSIS REV. O, WAS REVIEWED. RISK ID (B)(4) REFERS TO THE RISK OF PRESSURES ASSOCIATED WITH THE UNIT AND RISK TO THE PATIENT. THE RISK OF THOSE ITEMS RELATED TO HIGH PRESSURE (E.G., CO2 ABSORPTION (INTRAVASATION), HYPERCAPNIA, SUBCUTANEOUS EMPHYSEMA, PATIENTS EXPOSED TO HIGH PRESSURE, ETC.). THESE RISKS HAVE BEEN MITIGATED AS FOLLOWS: WARNING IN MANUAL ON DANGERS OF CO2 ABSORPTION, EMBOLISM, IDIOSYNCRATIC REACTIONS, METABOLIC AND CARDIAC REACTIONISM OVERSHOOT IS LIMITED TO FDA RECOMMENDATION NOT TO EXCEED 45MMHG FOR MORE THAN 15 SECONDS., OVERPRESSURE ALERT WILL ACTIVATE AT 5MMHG OVER THE PRESET AND A LAPSE OF LESS THAN OR EQUAL TO 5 SECONDS., MULTIPLE FAILURES ARE REQUIRED TO CAUSE OVERPRESSURE OF ABDOMINAL CAVITY. TEMPORARY DISABLING OF THE OVERPRESSURE ALERT WILL NOT EXCEED 30 SECONDS. IF THE DEVICE WERE TO BE DISPLAYING A HIGHER PRESSURE THAN ACTUAL THAT COULD BE A LOSS OF PNEUMO IF THE END USER REDUCED THE FLOW IN AN ATTEMPT TO BRING DOWN THE PRESSURE. A CLINICAL EVALUATION WAS PERFORMED PER (B)(4) WHICH PROVED THE BENEFITS OUTWEIGH THE RISKS. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Description of Event or Problem · 0

    ON 02/27/2025 NORTHGATE TECHNOLOGIES, INC WAS MADE AWARE OF THE ALLEGED EVENT, " DURING USE, OVERPRESSURIZATION OCCURRED, CAUSING THE LID OF THE WRAP DISK TO FLY OFF, AND THE PATIENT'S STOMACH TO SWELL. THE PATIENT'S VITAL SIGNS ALSO TEMPORARILY DROPPED BUT RECOVERED AND NO ADDITIONAL TREATMENT WAS REQUIRED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2613422 NEBULAE I LAPAROSCOPIC INSUFFLATOR HIF NORTHGATE TECHNOLOGIES INC. 7-650-00 00817183020189

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention