BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-T1

    MDR report key: 20785953 · Received November 26, 2024

    Report

    Report Number
    3001421318-2024-00172
    Event Type
    Malfunction
    Date Received
    November 26, 2024
    Date of Event
    December 18, 2023
    Report Date
    December 11, 2025
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002806091
    PMA / PMN Number
    K181216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG COMPLAINT NUMBER: (B)(4). INITIAL REPORT: THE INITIAL REPORT WAS ORIGINALLY SUBMITTED ON DATE 14-JAN-2024. FOR SOME UNKNOWN REASON HAMILTON MEDICAL AG NEVER RECEIVED AN ACKNOWLEDGEMENT NOTICE.

    Description of Event or Problem · 0

    THE FOLLOWING HAS BEEN REPORTED ZO HAMILTON MEDICAL AG ON DECEMBER 21ST 2023 CUSTOMER REPORTS, DEVICE ALARMS WITH A HIGH PRIORITY TECHNICAL EVENT: 231008. CUSTOMER HAS NOT PROVIDED LOG FILES. NO INTERRUPTION OF VENTILATION OR MEDICAL INTERVENTION WAS REPORTED. THIS RECORD CONTAINS NO INFORMATION OF PATIENT INVOLVEMENT. THE STATE OF VENTILATOR WHEN THE ALARM FIRST APPEARED IS UNKNOWN. NEITHER HARM TO PATIENT, USER OR THIRD PARTY NOR A TREATMENT DELAY WAS REPORTED ACCORDING TO PRELIMINARY ANALYSIS: POTENTIAL ROOT CAUSE COULD BE RELATED TO DEFECTIVE O2 PROPORTIONAL VALVE, MIXER ASSEMBLY OR LEAK IN LPO INLET. AS IMMEDIATE CORRECTION PERFORMED: - CHECK THE LPO INLET FOR LEAKS AS THIS COULD LEAD TO 231008 EVEN THOUGH THE O2 VALVE IS WORKING PROPERLY. IF HPO IS USED THEN MAKE SURE NO LPO CONNECTOR IS CONNECTED TO THE LPO INLET. AND - CHECK THE O2 MIXER FOR PROPER FUNCTION WITH SERVICE SOFTWARE, PNEUMATICS 2,O2 INPUT (PAGE 2112) AND SYSTEM TEST, O2 MIXER (PAGE 2203) AND - INSTALL LATEST SOFTWARE VERSION AND - REPLACE THE O2 MIXER ASSEMBLY

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2384208 HAMILTON-T1 HAMILTON-T1 CBK HAMILTON MEDICAL AG 161009 07630002806091

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown