BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPIRATORY VALVE SET

    MDR report key: 22051417 · Received May 20, 2025

    Report

    Report Number
    3001421318-2025-00607
    Event Type
    Malfunction
    Date Received
    May 20, 2025
    Date of Event
    May 5, 2025
    Report Date
    February 25, 2026
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    BYX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG COMPLAINT NUMBER: (B)(4). INITIAL REPORT.

    Additional Manufacturer Narrative · 0

    RATIONALE FOR USA (COUNTRY OF INCIDENT FRANCE). FINAL REPORT - HAMILTON MEDICAL AG COMPLAINT NUMBER: (B)(4). THE ANALYSIS OF THE PROVIDED LOG FILES SHOW THAT THE VENTILATOR DISPLAYED THE ERROR MESSAGE: ¿WRONG EXPIRATORY VALVE¿ WHICH CLEARED WITHIN SECONDS DURING THE PRE-OPERATIONAL CHECKS. AFTER THE PATIENT WAS CONNECTED TO THE VENTILATOR, ABOUT 30 MINUTES LATER, THE DEVICE ALARMED ¿VT LOW¿ ¿LOW MINUTE VOLUME¿, ¿PRESSURE LIMITATION¿ ¿HIGH FREQUENCY¿ ¿INSPIRATORY VOLUME LIMITATION¿ FOLLOWED BY THE ¿EXHALATION OBSTRUCTED¿ ALARM. THE COMBINATION OF THE ABOVE-MENTIONED ALARMS COULD LEAD TO INCREASING AIRWAY RESISTANCE OR OBSTRUCTION, INCLUDING IN THE EXHALATION LIMB OF THE VENTILATOR CIRCUIT. ACCORDING TO THE HAMILTON-MR1 OPERATOR MANUAL, THE OPERATOR MUST CHECK IF THE EXPIRATORY VALVE IS AFFECTED BY ANY NEBULIZING AGENT. CHECK WHETHER THERE IS A DISCONNECTION AT THE EXPIRATORY VALVE. CHECK THE BREATHING CIRCUIT AND ARTIFICIAL AIRWAY OF THE PATIENT FOR LEAKS, KINKED LIMBS OR TUBING, OR DISCONNECTION. THE EXACT CAUSE OF THE INCIDENT COULD NOT BE DETERMINED, HOWEVER, DURING ONSITE TROUBLESHOOTING, THE EXPIRATORY VALVE WAS REPLACED WITH A REUSABLE EXPIRATORY VALVE AND "VENTILATION RESUMED WITHOUT ERROR". THERE WAS NO REPORTED IMPACT FOR THE INVOLVED PATIENT.

    Description of Event or Problem · 0

    HAMILTON MEDICAL AG RECEIVED THE FOLLOWING INCIDENT DESCRIPTION: ALL MACHINE TESTS WERE VALIDATED. BAG VENTILATION WAS NORMAL. CONNECTION TO THE PATIENT (INTUBATED NEONATAL), AFTER 4 OR 5 VENTILATION CYCLES, A "CLACK, CLACK, CLACK" NOISE WAS HEARD FROM THE EXPIRATORY VALVE, FOLLOWED BY AN EXHALATION OBSTRUCTED AUDIBLE ALARM. THE SINGLE USE EXPIRATORY VALVE SET (PN 161189) GOT REPLACED BY THE SAME TYPE SINGLE USE EXPIRATORY VALVE SET (PN 161189). THE SAME PROBLEMS OCCURRED AGAIN. SUBSEQUENTLY A REUSABLE TYPE OF EXPIRATORY VALVE SET (PN 161188) GOT INSTALLED INSTEAD AND THE TREATMENT COULD BE CONTINUED. THE ISSUE DID NOT RESULT IN ANY PATIENT HARM NOR A DELAY IN TREATMENT. THE HAMILTON-MR1 VENTILATOR DEVICE LOG FILES SHOWN THAT THE VENTILATOR DEVICE ALARMED WITH "WRONG EXPIRATORY VALVE" UPON START-UP ON (B)(6) 2025, AND PRE OP CHECKS PASSED. ABOUT 30 MINUTES LATER, THE DEVICE ALARMED WITH VARIOUS MEDIUM AND HIGH PRIORITY ALARMS, INCLUDING: EXHALATION OBSTRUCTED, HIGH FREQUENCY CONDITION, LOW MINUTE VOLUME, INSPIRATORY VOLUME LIMITATION, HIGH MINUTE, AND PRESSURE LIMITATION. DUE TO THE DESCRIBED ISSUE, A POTENTIAL IMPACT ON THE PATIENT COULD NOT BE EXCLUDED. THEREFORE, THE EVENT WAS ASSESSED AS REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2129139 EXPIRATORY VALVE SET EXPIRATORY VALVE SET BYX HAMILTON MEDICAL AG 161189 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown