BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BREATHING CIRCUITS

    MDR report key: 24673952 · Received March 24, 2026

    Report

    Report Number
    3001421318-2026-00157
    Event Type
    Malfunction
    Date Received
    March 24, 2026
    Date of Event
    February 26, 2026
    Report Date
    March 23, 2026
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CAI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG REF NR: COMP-(B)(4). INVESTIGATION OUTCOME: IT WAS REPORTED THAT WE HAVE HAD SEVERAL OCCURRENCES OF "EXHALATION OBSTRUCTED" ON OUR VENTS. THE DEVICE PASSES PRE-OP CHECKS BUT ONCE VENTILATION STARTS, IT ALARMS "EXHALATION OBSTRUCTED" . THERE WAS NO OBSTRUCTION TO THE EXPIRATORY BLEED PORT. WHEN TESTING THE DEVICE WITH THE CLINICAL ENGINEERING TEST EXPIRATORY VALVE, IT PASSES. TESTING WITH THE USER PROVIDED CIRCUITS (PRODUCT REF: 260128, LOT NO. 201868), THE TEST WOULD FAIL. I OPENED UP TWO MORE CIRCUITS BELONGING TO THE SAME LOT NUMBER AND THE RESULT WAS THE SAME. A BREATHING CIRCUIT BELONGING TO LOT NO. 201894 WAS ALSO TESTED AND IT PASSED. THE MOST PROBABLE ROOT CAUSE WAS A STICKY MEMBRANE OR FAULTY EXPIRATORY VALVE AS PART OF THE BREATHING CIRCUIT SET. HOWEVER, THIS COULD NOT BE CONFIRMED AS HAMILTON MEDICAL AG DID NOT RECEIVE THE BREATHING CIRCUITS ASSOCIATED WITH THIS SPECIFIC CASE. THE ISSUE WAS RESOLVED BY REPLACING THE AFFECTED BREATHING CIRCUIT SET WITH ANOTHER ONE. NO FURTHER INFORMATION WAS RECEIVED. THIS CASE IS CONSIDERED AS CLOSED.

    Description of Event or Problem · 0

    HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: "WE HAVE HAD SEVERAL OCCURRENCES OF "EXHALATION OBSTRUCTED" ON OUR VENTS. THE DEVICE PASSES PRE-OP CHECKS BUT ONCE VENTILATION STARTS, IT ALARMS "EXHALATION OBSTRUCTED". THERE WAS NO OBSTRUCTION TO THE EXPIRATORY BLEED PORT. WHEN TESTING THE DEVICE WITH THE CLINICAL ENGINEERING TEST EXPIRATORY VALVE, IT PASSES. TESTING WITH THE USER PROVIDED CIRCUITS (PRODUCT REF: 260128, LOT NO. 201868), THE TEST WOULD FAIL. I OPENED UP TWO MORE CIRCUITS BELONGING TO THE SAME LOT NUMBER AND THE RESULT WAS THE SAME. A BREATHING CIRCUIT BELONGING TO LOT NO. 201894 WAS ALSO TESTED AND IT PASSED." NO HEALTH CONSEQUENCES OR IMPACT. CIRCUITS WERE CHANGED MULTIPLE TIMES TO CORRECT THE ISSUE. THE CASE HAS NOT BEEN REVIEWED YET BY HAMILTON MEDICAL AG. THEREFORE THE FAILURE DESCRIPTION COULD NOT BE CONFIRMED YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737695 BREATHING CIRCUITS BREATHING CIRCUITS CAI HAMILTON MEDICAL AG 260128

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown