BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BREATHING CIRCUIT SET

    MDR report key: 25148092 · Received May 12, 2026

    Report

    Report Number
    3001421318-2026-00298
    Event Type
    Malfunction
    Date Received
    May 12, 2026
    Date of Event
    April 28, 2026
    Report Date
    May 12, 2026
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    BZO
    UDI-DI
    07630002802956
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG REFERENCE NUMBER: (B)(4). INVESTIGATION IS ONGOING. HAMILTON COAXIAL BREATHING CIRCUIT FAMILY DEVICES IN THIS PRODUCT LINE ARE CLASSIFIED UNDER PRODUCT CODE BZO. ¿SET,TUBING AND SUPPORT, VENTILATOR (WITH HARNESS). PART NUMBER 260127 IS LISTED IN THE SAME PRODUCT FAMILY PER THE MANUFACTURER ¿S IFU, AND THEREFORE FALLS UNDER THE SAME FDA PRODUCT CLASSIFICATION.

    Description of Event or Problem · 0

    IT WAS REPORTED TO HAMILTON MEDICAL AG, THAT: "ON APRIL 28TH, 2026 THE HAMILTON-T1 (PN 161006 / SN (B)(6) AND BREATHING CIRCUIT SET (PN 260167 / LN 202482) EXPERIENCED ISSUES WITH VENTILATION ON A 9-YEAR-OLD PATIENT DURING TRANSFER FROM THE OPERATING THEATER. WHEN STARTING THE VENTILATION IN ASV MODE, IT SAYS "EXPIRATION BLOCKED". AFTER SEVERAL ATTEMPTS AT TROUBLESHOOTING, VENTILATION MODE WAS SWITCHED TO PRESSURE-CONTROLLED MODE INSTEAD, WHICH WORKED WITHOUT PROBLEMS. THE VENTILATOR WAS CORRECTLY SET AT A HEIGHT THAT CORRESPONDED TO THE CHILD'S WEIGHT - 32 KG." PATIENT INVOLVEMENT WITH MEDICAL INTERVENTION (SWITCHING OF VENTILATION MODE TO PREVENT POTENTIAL HARM TO THE PATIENT) BUT NO PATIENT, USER OR THIRD PARTY HARM WAS REPORTED. FOR THIS SPECIFIC EVENT, THE LOG FILES WERE PROVIDED. A REVIEW OF THE LOG FILES CONFIRMED THE OCCURRENCE OF THE ALARM "EXHALATION OBSTRUCTED" ON THE REPORTED EVENT DATE OF APRIL 28TH, 2026: 82/2026-04-28 14:43:31/!!! /EXHALATION OBSTRUCTED 164/(B)(6) 2026 14:40:36/!!! /EXHALATION OBSTRUCTED 217/ (B)(6) 2026 14:31:29/!!! /EXHALATION OBSTRUCTED 221/(B)(6) 2026 14:31:12/!!! /EXHALATION OBSTRUCTED 225/(B)(6) 2026 14:30:48/!!! /EXHALATION OBSTRUCTED 229/(B)(6) 2026 14:30:27/!!! /EXHALATION OBSTRUCTED 233/(B)(6) 2026 14:30:06/!!! /EXHALATION OBSTRUCTED 240/(B)(6) 2026 14:29:45/!!! /EXHALATION OBSTRUCTED 244/(B)(6) 2026 14:29:24/!!! /EXHALATION OBSTRUCTED 250/(B)(6) 2026 14:29:08/!!! /EXHALATION OBSTRUCTED 297/(B)(6) 2026 14:25:32/START /TF PROCESSING STARTED 309/(B)(6) 2026 14:25:21/POWER /ON VENTILATION SOFTWARE ADDITIONALLY, THE "EXHALATION OBSTRUCTED" ALARM ALSO OCCURRED ON EARLIER DATES: 1378/(B)(6) 2026 12:39:16/!!! /EXHALATION OBSTRUCTED CONDITION REMOVED. 1382/(B)(6) 2026 12:39:07/!!! /EXHALATION OBSTRUCTED. 1386/(B)(6) 2026 12:39:00/!!! /EXHALATION OBSTRUCTED CONDITION REMOVED. 1389/(B)(6)2026 12:38:51/!!! /EXHALATION OBSTRUCTED. 1438/(B)(6) 2026 12:37:59/START /TF PROCESSING STARTED. 1450/(B)(6) 2026 12:37:47/POWER /ON VENTILATION SOFTWARE. ... 3276/(B)(6) 2025 02:08:34/!!! /EXHALATION OBSTRUCTED CONDITION REMOVED. 3277/(B)(6) 2025 02:08:24/!!! /EXHALATION OBSTRUCTED. 3328/(B)(6) 2025 01:54:00/START /TF PROCESSING STARTED. 3340/(B)(6) 2025-12-08 01:53:49/POWER /ON VENTILATION SOFTWARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208180 BREATHING CIRCUIT SET BREATHING CIRCUIT SET BZO HAMILTON MEDICAL AG 260167 202482 07630002802956

    Patients

    Seq Age Sex Outcome Treatment
    1