BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-T1

    MDR report key: 24480825 · Received March 2, 2026

    Report

    Report Number
    3001421318-2026-00097
    Event Type
    Malfunction
    Date Received
    March 2, 2026
    Date of Event
    February 23, 2026
    Report Date
    March 19, 2026
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    PMA / PMN Number
    K181216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AGS REFERENCE: (B)(4). HAMILTON MEDICAL AGS CONCLUSION: IT WAS REPORTED THAT THE HAMILTON-T1 VENTILATOR ALARMED FOR ¿EXHALATION OBSTRUCTED¿ DURING VENTILATION. AS DEVICE LOGS WERE NOT AVAILABLE, THE EXACT CIRCUMSTANCES OF THE EVENT COULD NOT BE VERIFIED. TESTING OF THE VENTILATOR WITH THREE DIFFERENT EXHALATION VALVE COVERS SHOWED NO ABNORMALITIES, AND THE ISSUE WAS ISOLATED TO A SINGLE VALVE COVER FROM LOT 202977 OR 202455. THE FINDINGS ARE CONSISTENT WITH A BLOCKAGE IN THE AFFECTED VALVE COVER, POTENTIALLY RELATED TO THE MEMBRANE. A REVIEW OF THE CUSTOMER¿S INVENTORY CONFIRMED THAT NO ADDITIONAL COVERS FROM THESE LOTS REMAINED IN USE. SERVICE SOFTWARE CHECKS WERE PERFORMED IN ACCORDANCE WITH MANUFACTURER SPECIFICATIONS, AND ALL FUNCTIONAL TESTS WERE PASSED. BASED ON THE AVAILABLE INFORMATION, THE DEVICE OPERATES AS INTENDED AND NO CLINICAL IMPACT HAS BEEN REPORTED. CASE CONSIDERED CLOSED.

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG REF. NR: (B)(4); INVESTIGATION ONGOING. NOTE: UDI AND MANUFACTURING DATE ARE NOT YET AVAILABLE DUE TO INCOMPLETE INFORMATION AND PENDING CONFIRMATION OF THE AFFECTED DEVICE DETAILS RECEIVED.

    Description of Event or Problem · 0

    HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: EXHALATION OBSTRUCTION MESSAGES. SENT QUESTIONNAIRE TO CUSTOMER THEY DO NOT KNOW OCCURRENCE DATE. VENTILATOR WAS ON A PATIENT BUT ALL OTHER VALUES UNKNOWN BUT ANSWERED NO DUE TO LIMITATIONS - NO HEALTH CONSEQUENCES OR IMPACT - NO INTERVENTION NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    540027 HAMILTON-T1 HAMILTON-T1 CBK HAMILTON MEDICAL AG 161006

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown