BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BREATHING CIRCUIT SET

    MDR report key: 25297175 · Received May 27, 2026

    Report

    Report Number
    3001421318-2026-00313
    Event Type
    Malfunction
    Date Received
    May 27, 2026
    Date of Event
    April 21, 2026
    Report Date
    May 27, 2026
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    BZO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG REFERENCE NUMBER: (B)(4). INVESTIGATION IS ONGOING. FSCA INITIATED BY HAMILTON MEDICAL AG, INTERNAL REFERENCE NUMBER: (B)(4). FDA REF: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED TO HAMILTON MEDICAL AG, THAT: ON (B)(6) 2026, A MALFUNCTION OCCURRED INVOLVING A HAMILTON-T1 VENTILATOR (PN 161009 / SN (B)(6)) DURING PATIENT USE AT SPITAL HIRSLANDEN. THE ISSUE OCCURRED DURING THE TRANSFER OF AN INTUBATED PATIENT. ALL PRE-USE CHECKS HAD BEEN COMPLETED SUCCESSFULLY AND NO ABNORMALITIES WERE IDENTIFIED PRIOR TO USE. HOWEVER, AFTER THE VENTILATOR WAS CONNECTED TO THE PATIENT, THE DEVICE MALFUNCTIONED. SPECIFICALLY, THE VENTILATOR DELIVERED INSPIRATORY BREATHS, BUT EXPIRATION DID NOT OCCUR PROPERLY. AN ALARM INDICATED THAT EXPIRATION MIGHT BE BLOCKED. TROUBLESHOOTING MEASURES, INCLUDING DISCONNECTING THE DEVICE, RESTARTING IT, AND REPEATING DEVICE CHECKS, WERE PERFORMED, BUT THE MALFUNCTION PERSISTED. AS A RESULT, AIR ENTERED THE PATIENT BUT COULD NOT BE EFFECTIVELY EXHALED, AND THE VENTILATOR COULD NO LONGER BE USED SAFELY. MANUAL VENTILATION USING A BAG-VALVE MASK WAS THEREFORE REQUIRED DURING PATIENT TRANSPORT IN ORDER TO MAINTAIN ADEQUATE VENTILATION. PATIENT INVOLVEMENT WITH MEDICAL INTERVENTION (MANUAL VENTILATION USING A BAG-VALVE MASK) WAS REPORTED. HOWEVER, NO PATIENT, USER OR THIRD PARTY HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530743 BREATHING CIRCUIT SET BREATHING CIRCUIT SET BZO HAMILTON MEDICAL AG UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1