BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-T1

    MDR report key: 18903148 · Received March 14, 2024

    Report

    Report Number
    3001421318-2024-00603
    Event Type
    Malfunction
    Date Received
    March 14, 2024
    Date of Event
    February 8, 2024
    Report Date
    November 24, 2025
    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
    003

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG COMPLAINT NUMBER: (B)(4). FOLLOW-UP 1 - CORRECTED INFORMATION: **UDI RELATED DATA QUALITY UPDATES ONLY** FIELD D4 WAS UPDATED WITH FULL UDI INFORMATION. UPDATED FIELDS: B4, D1, D3, D4, G6, H2, H4, H11.

    Additional Manufacturer Narrative · 0

    THE ISSUE OCCURRED DURING VENTILATION OF A PATIENT. NO HARM TO THE PATIENT WAS REPORTED. THE ROOT CAUSE OF THE EVENT WAS DETERMINED TO BE A DEFECTIVE O2 MIXER ASSEMBLY. AFTER REPLACING THE O2 MIXER ASSEMBLY, THE DEVICE WAS RELEASED BACK INTO USE.

    Description of Event or Problem · 0

    THE FOLLOWING HAS BEEN REPORTED TO HAMILTON MEDICAL AG ON FEB 16TH 2024. CUSTOMER REPORTED THAT THIS EVENT OCCURRED ON FEBRUARY 8 2024, IMVOLVING A HAMILTON T1 (SN (B)(6)) VENTILATOR WAS IN HIGH FLOW OXYGEN THERAPY MODE USING AN OPTI-FLOW CANNULA WHEN HIGH PRIORITY ALARM TF 23008 AND 231007 FIRST APPEARED. LOGS FILES ARE NOT AVAILABLE AT THE TIME OF ENTRY. ACCORDING TO THE REPORTER, THE STAFF SAY THAT NOTHING WAS CONNECTED TO THE LPO PORT. ACCORDING THE PRELIMINARY ANALYSIS, THE ROOT CAUSE COULD BE RELATED TO EFECTIVE O2 PROPORTIONAL VALVE, MIXER ASSEMBLY OR LEAK IN LPO INLET AS PER AVAIALBLE INFORMATION THERE IS NO INDICATION THAT THE COMPLAINT LEAD TO DEATH, INJURY OR SERIOUS DETERIORATION OF THE HEALTH OF THE PATIENT, USER OR THIRD-PARTY.

    Description of Event or Problem · 0

    THE FOLLOWING HAS BEEN REPORTED TO HAMILTON MEDICAL AG ON FEB 16TH 2024. CUSTOMER REPORTED THAT THIS EVENT OCCURRED ON FEBRUARY 8 2024, INVOLVING A HAMILTON T1 (SN (B)(6)) VENTILATOR WAS IN HIGH FLOW OXYGEN THERAPY MODE USING AN OPTI-FLOW CANNULA WHEN HIGH PRIORITY ALARM TF 23008 AND 231007 FIRST APPEARED. LOGS FILES ARE NOT AVAILABLE AT THE TIME OF ENTRY. ACCORDING TO THE REPORTER, THE STAFF SAY THAT NOTHING WAS CONNECTED TO THE LPO PORT. ACCORDING THE PRELIMINARY ANALYSIS, THE ROOT CAUSE COULD BE RELATED TO EFECTIVE O2 PROPORTIONAL VALVE, MIXER ASSEMBLY OR LEAK IN LPO INLET. AS PER AVAIALBLE INFORMATION THERE IS NO INDICATION THAT THE COMPLAINT LEAD TO DEATH, INJURY OR SERIOUS DETERIORATION OF THE HEALTH OF THE PATIENT, USER OR THIRD-PARTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2093206 HAMILTON-T1 HAMILTON-T1 CBK HAMILTON MEDICAL AG 161006 07630002801850

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown