BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPIRATORY VALVE SET

    MDR report key: 25067021 · Received May 4, 2026

    Report

    Report Number
    3001421318-2026-00248
    Event Type
    Malfunction
    Date Received
    May 4, 2026
    Date of Event
    April 16, 2026
    Report Date
    May 4, 2026
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    BZO
    UDI-DI
    07630002802963
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    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 260128 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: OVER THE PAST WEEK, THE STAFF HAS EXPERIENCES "OBSTRUCTION ALARMS" AND LOW PEEP, LOW VT ALARMS ON THE BREATHING CIRCUITS WITH PN 260128 / LN 020926-7 (QTY: 6) FOR THE HAMILTON FAMILY-1 SERIES VENTILATORS. THE STAFF ASSERT THAT THE BREATHING CIRCUITS WITH ARE PASSING THE PRE-OP TEST. THE PROVIDED EVENT DATE IS APRIL 16, 2026. PATIENT INVOLVEMENT WAS REPORTED AS WELL AS MEDICAL INTERVENTION (REPLACEMENT OF THE BREATHING CIRCUIT ON THE PATIENT). HOWEVER, NO PATIENT, USER OR THIRD PARTY IMPACT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    482672 EXPIRATORY VALVE SET EXPIRATORY VALVE SET BZO HAMILTON MEDICAL AG 260128 020926-7 07630002802963

    Patients

    Seq Age Sex Outcome Treatment
    1