BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 18370782 · Received December 21, 2023

    Report

    Report Number
    3001421318-2023-04301
    Event Type
    Malfunction
    Date Received
    December 21, 2023
    Date of Event
    December 5, 2023
    Report Date
    December 3, 2025
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002808590
    PMA / PMN Number
    K201658
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    THE FOLLOWING HAS BEEN REPORTED ZO HAMILTON MEDICAL AG ON DECEMBER 12TH 2023: DURING VENTILATOR TRIAL POTENTIAL CUSTOMER STATES THAT WHEN PATIENT'S NCPAP INTERFACE BECAME DISLODGED FROM PATIENT THERE WAS NO ALARM AVAILABLE TO ALERT THE CLINICIAN. LOW PRESSURE ALARM IS NOT USEFUL AS THE C6'S LEAK COMPENSATION DID NOT ALLOW PRESSURE TO DROP. THIS EVENT REQUIRED MEDICAL INTERVENTION : HYPEROXYGENATED TO COMPENSATE FOR DROPPED SATURATIONS NO INDICATION THAT THE COMPLAINT LEAD TO DEATH, INJURY OR SERIOUS DETERIORATION OF THE HEALTH OF THE PATIENT, USER OR THIRD-PARTY. PRELIMINARY ANALYSIS OF THE LOG FILE REVEALED THE FOLLOWING: 196/2023-12-05 07:59:13/CONTROL /PATIENT GROUP NEONATAL 197/2023-12-05 07:59:13/START /ON 198/2023-12-05 07:59:13/CONTROL /TI MAX => 1.00 S 199/2023-12-05 07:59:13/CONTROL /ETS => 25 % 200/2023-12-05 07:59:13/CONTROL /P-RAMP => 50 MS 201/2023-12-05 07:59:13/CONTROL /OXYGEN => 21 % 202/2023-12-05 07:59:13/CONTROL /FLOW TRIGGER => 0.5 L/MIN 203/2023-12-05 07:59:13/CONTROL /PEEP => 6.0 CMH2O 204/2023-12-05 07:59:13/CONTROL /PINSP => 14.0 CMH2O 205/2023-12-05 07:59:13/CONTROL /TI => 0.35 S 206/2023-12-05 07:59:13/CONTROL /RATE => 40 B/MIN 207/2023-12-05 07:59:13/CONFIG /VT/KG => 5 ML/KG 208/2023-12-05 07:59:13/ALARM /FTOTAL (LOW) => 7 B/MIN 209/2023-12-05 07:59:13/ALARM /FTOTAL (HIGH) => 133 B/MIN 210/2023-12-05 07:59:13/ALARM /PLIMIT => 20 CMH2O 211/2023-12-05 07:59:13/ALARM /PRESSURE (LOW) => 5 CMH2O 212/2023-12-05 07:59:13/ALARM /PRESSURE (HIGH) => 30 CMH2O 213/2023-12-05 07:59:13/ALARM /APNEA TIME => 5 S 214/2023-12-05 07:59:13/SPECIAL /VENTILATION TIME => 367 MIN 215/2023-12-05 07:59:13/CONTROL /WEIGHT => 0.75 KG 216/2023-12-05 07:59:13/MODE /STANDBY => NCPAP-PS --[18.12.2023 20:39] - DISCONNECT ALARM NIV MODE C6 INVESTIGATION ARE ONGOIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2052821 HAMILTON MEDICAL AG HAMILTON-C6 VENTILATOR CBK HAMILTON MEDICAL AG HAMILTON-C6 07630002808590

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown