BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-T1

    MDR report key: 21907453 · Received April 25, 2025

    Report

    Report Number
    3001421318-2025-00558
    Event Type
    Malfunction
    Date Received
    April 25, 2025
    Date of Event
    April 10, 2025
    Report Date
    February 18, 2026
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002801850
    PMA / PMN Number
    K181216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG COMPLAINT NUMBER: (B)(4). INITIAL REPORT.

    Additional Manufacturer Narrative · 0

    INVESTIGATION OUTCOME: IT WAS REPORTED THAT AFTER SUCCESSFUL COMPLETION OF PNEUMATICS 1 > EXP. VALVE > NEONATAL TEST, THE BLOWER DID NOT TURN OFF. A BLOWER CONTINUING TO RUN AFTER A SUCCESSFUL TEST DOES NOT POSE ANY RISK. THE ISSUE COULD NOT BE REPLICATED. NO MALFUNCTION WITH THE DEVICE COULD BE REPRODUCED. THERE WAS NO RISK ASSOCIATED WITH THIS EVENT. THERE WAS NO PATIENT INVOLVEMENT AS IT OCCURRED DURING TESTS. THIS CASE IS CONSIDERED AS CLOSED.

    Description of Event or Problem · 0

    THE BLOWER DID NOT TURN OFF AFTER SUCCESSFUL COMPLETING THE SERVICE SOFTWARE TEST NAMED ¿PNEUMATICS 1 > EXP. VALVE > NEONATAL¿. MOVED TO A DIFFERENT TEST SCREEN AND BACK TO THE TEST. THE ISSUE COULD NOT BE REPLICATED. AFTER A WHILE THE TECHNICAL EVENT TE 231001 (PRESSURECONTROLLERPRESSURELOW) GOT DISPLAYED. THERE IS NO PATIENT INVOLVEMENT AND THE ISSUE COULD NOT BE REPLICATED. HOWEVER, IF IT WOULD RECUR DURING VENTILATION, A DETERIORATION OF PATIENT HEALTH COULD NOT BE EXCLUDED BASED ON THE PROVIDED CURRENT INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    484381 HAMILTON-T1 HAMILTON-T1 CBK HAMILTON MEDICAL AG 161006 07630002801850

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown