BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BREATHING CIRCUIT SET

    MDR report key: 25135673 · Received May 11, 2026

    Report

    Report Number
    3001421318-2026-00294
    Event Type
    Malfunction
    Date Received
    May 11, 2026
    Date of Event
    April 30, 2026
    Report Date
    May 11, 2026
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    BZO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG REFERENCE NUMBER: (B)(4). INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    IT WAS REPORTED TO HAMILTON MEDICAL AG, THAT: ON (B)(6) 2026, A HAMILTON-T1 VENTILATOR (PN 161006 / SN (B)(6) AND A BREATHING CIRCUIT SET (PN UNKNOWN / LN UNKNOWN) PASSED PRE-OPERATIONAL SAFETY CHECKS BUT FAILED TO VENTILATE THE PATIENT SCHEDULED FOR A CT SCAN. ONCE CONNECTED TO THE PATIENT FOR VENTILATION, A MESSAGE READING "OBSTRUCTION" APPEARED. EVENTUALLY IT FUNCTIONED ON VC VENTILATION MODE. THE SAME ISSUE OCCURRED WITH THE SAME PATIENT BUT A SECOND HAMILTON VENTILATOR DOWN IN THE CT SCANNER, WITH THE TUBING CHANGED TWICE. THE PATIENT WAS THEN PLACED BACK ON A SERVO VENTILATOR WITH NO ISSUES. A 45-MINUTE DELAY TO THE CT SCAN WAS REPORTED. PATIENT INVOLVEMENT WITH MEDICAL INTERVENTION AND NO PATIENT, USER OR THIRD PARTY HARM WAS REPORTED. FOR THIS SPECIFIC CASE, LOGFILES FOR THE HAMILTON-T1 VENTILATOR WERE PROVIDED: LINE 70: 60/2026-04-30 17:17:19/!!! /EXHALATION OBSTRUCTED CONDITION REMOVED LINE 72: 62/2026-04-30 17:17:11/!!! /EXHALATION OBSTRUCTED LINE 74: 64/2026-04-30 17:17:05/!!! /EXHALATION OBSTRUCTED CONDITION REMOVED LINE 77: 67/2026-04-30 17:16:57/!!! /EXHALATION OBSTRUCTED LINE 79: 69/2026-04-30 17:16:48/!!! /EXHALATION OBSTRUCTED CONDITION REMOVED LINE 81: 71/2026-04-30 17:16:41/!!! /EXHALATION OBSTRUCTED LINE 83: 73/2026-04-30 17:16:35/!!! /EXHALATION OBSTRUCTED CONDITION REMOVED LINE 85: 75/2026-04-30 17:16:27/!!! /EXHALATION OBSTRUCTED LINE 87: 77/2026-04-30 17:16:21/!!! /EXHALATION OBSTRUCTED CONDITION REMOVED LINE 90: 80/2026-04-30 17:16:13/!!! /EXHALATION OBSTRUCTED LINE 150: 140/2026-04-30 17:14:17/!!! /EXHALATION OBSTRUCTED CONDITION REMOVED LINE 151: 141/2026-04-30 17:14:09/!!! /EXHALATION OBSTRUCTED LINE 153: 143/2026-04-30 17:14:00/!!! /EXHALATION OBSTRUCTED CONDITION REMOVED LINE 156: 146/2026-04-30 17:13:52/!!! /EXHALATION OBSTRUCTED LINE 159: 149/2026-04-30 17:13:46/!!! /EXHALATION OBSTRUCTED CONDITION REMOVED LINE 162: 152/2026-04-30 17:13:38/!!! /EXHALATION OBSTRUCTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42811 BREATHING CIRCUIT SET BREATHING CIRCUIT SET BZO HAMILTON MEDICAL AG UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1