BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 16673417 · Received April 4, 2023

    Report

    Report Number
    3001421318-2023-01207
    Event Type
    Malfunction
    Date Received
    April 4, 2023
    Date of Event
    March 20, 2023
    Report Date
    March 13, 2024
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002800747
    PMA / PMN Number
    K181216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG CASE NUMBER IS: (B)(4). INVESTIGATION: LOG FILES ANALYSIS: THE EVENT LOG CONFIRMS THE APPEARANCE OF THE TECHNICAL EVENT: 231008 WHEN THE DEVICE WAS STARTED-UP IN SERVICE MODE. AFTER POWER OFF AND POWER-ON IN USER MODE, THE ALARM CONTINUED TO REAPPEAR AFTER THE VENTILATION WAS STARTED FOR TESTING PURPOSES. IN CASE THE FIO2 IS SET TO 21%, THE O2 MIXER (PROPORTIONAL VALVE) IS CLOSED. THE INTERNAL FLOW SENSOR (QO2) IS USED TO MONITOR AN EVENTUAL LEAK FLOW FROM HPO THROUGH THE O2 MIXER VALVE. IN CASE THE QO2 SENSOR DETECTS A FLOW AT FIO2=21% THEN THE TECHNICAL EVENT: 231008 APPEARS TO INDICATE AN O2 VALVE LEAK. THE TECHNICAL EVENT: 231007 CAN APPEARS AS AFTER EFFECT AND INDICATES THAT THE CONTROLLER IS AT ITS MAX. LIMIT TO KEEP CLOSE THE VALVE (O2CONTROLLERFLOWHIGH) A REASON FOR TRIGGERING THIS ALARM CONDITION COULD BE BECAUSE OF A: -DEFECTIVE O2 MIXER (O2 VALVE NOT PROPERLY CLOSING. MECHANICALLY OR ELECTRONICALLY) -LEAK ON THE LPO INLET OR BETWEEN O2 MIXER AND QO2 SENSOR. IN THIS CASE BLOWER SUCKS THE AIR THROUGH THE LPO ADAPTER THROUGH QO2 SENSOR, WHICH CREATES A FALSE POSITIVE ALARM. LPO ADAPTER (QUICK CONNECT COUPLING) IS STILL INSERTED, WHILE THE DEVICE IS SET TO HPO. IN THIS CASE BLOWER SUCKS THE AIR OVER THE LPO ADAPTER THROUGH QO2 SENSOR, WHICH CREATES A FALSE POSITIVE ALARM->USER ERROR - DRIVER BOARD AS CAUSE. THE O2 VALVE DRIVER STAGE CONTROLS THE O2 PROPORTIONAL VALVE AND IS LOCATED ON THE DRIVER BOARD. IN THIS PARTICULAR CASE, THE O2 MIXER ASSEMBLY WAS REPLACED AND CONFIRMED THAT THE LPO WAS NOT CONNECTED. THE ROOT CAUSE OF THE VENTILATOR TO ALARM WITH "TECHNICAL EVENT: 231008" WAS A MALFUNCTION OF THE O2 MIXER VALVE CAUSING A LEAK. (MECHANICALLY JAMMED DUE STORAGE OF THE DEVICE FOR A LONG PERIOD BEFORE USAGE).

    Additional Manufacturer Narrative · 0

    O2 MIXER ASSEMBLY REPLACED WAS REPLACED AND THE DEVICE WORKED AS INTENDED. HAMILTON MEDICAL AG CASE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: TECHNICAL EVENT (O2 VALVE LEAK). AT THE STANDBY O2 FLOWSENSOR MEASURED 2,3L FLOW. MIXER VALVE DID NOT CLOSE. NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: TECHNICAL EVENT (O2 VALVE LEAK). AT THE STANDBY O2 FLOWSENSOR MEASURED 2,3L FLOW. MIXER VALVE DID NOT CLOSE. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391753 HAMILTON MEDICAL AG HAMILTON-C1 CBK HAMILTON MEDICAL AG HAMILTON-C1 07630002800747

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown