BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-T1

    MDR report key: 19640368 · Received June 29, 2024

    Report

    Report Number
    3001421318-2024-01561
    Event Type
    Malfunction
    Date Received
    June 29, 2024
    Date of Event
    May 31, 2024
    Report Date
    November 3, 2025
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002801850
    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). FOLLOW-UP 1 - CORRECTED INFORMATION: UDI RELATED DATA QUALITY UPDATES ONLY. FIELD D4 WAS UPDATED WITH FULL UDI INFORMATION.

    Description of Event or Problem · 0

    THE FOLLOWING HAS BEEN REPORTED TO HAMILTON MEDICAL AG ON 03 JUNE 2024. IT WAS REPORTED BY HAMILTON MEDICAL INC, THAT ON 31 MAY 2024 DURING PREVENTIVE MAINTENANCE, A HAMILTON T1 VENTILATOR ((B)(6)) FAILED DURING FLOW TEST. NEED TO ORDER CHECK VALVE ASSEMBLY ACCORDING TO THE PRELIMINARY INVESTIGATION PERFORMED, POTENTIAL ROOT CAUSE ASSOCIATED TO THE REPORTED ISSUE ARE AS FOLLOW: EXTERNAL DEVICE IS SET TO STLD INSTEAD OF ATP. EXTERNAL FS NOT CALIBRATED. DEFECTIVE EXTERNAL FS. LEAK (E.G OBSTRUCTION VALVE, TUBING, FS). RINSE FLOW ASYMMETRIC. OSCILLATION, TURBULENCE BEFORE QVENT SENSOR (1ST GENERATION). DEFECTIVE QVENT SENSOR. PFLOW SENSOR DEFECT, AZ LEAKAGE (PRESSURE SENSOR ASSEMBLY). THE FOLLOWING CORRECTION CAN BE CONSIDERED ACCORDINGLY: MAKE SURE THE EXTERNAL MEASUREMENT IS SET TO ATP. IF QVENT DOES NOT MATCH THE EXTERNAL MEASUREMENT THEN: CHECK FOR LEAKS (CHECK OBSTRUCTION VALVE). INSTALL FLOW MESH MSP161944 (1ST GEN HW ONLY, SEE KB-ID 3145). REPLACE QVENT IF PROBLEM REMAINS. IF QVENT MATCHS EXTERNAL MEASUREMENT, BUT QAW IS OUT OF RANGE, THEN: CHECK EXPIRATORY VALVE / MEMBRANE COVER IF PROPERLY SEATED. CHECK BREATHING CIRCUIT FOR LEAK. CALIBRATE FLOW SENSOR. CHECK RINSE FLOW. REPLACE FLOW SENSOR. REPORTEDLY, THERE NO PATIENT INVOLVED. ACCORDING TO THE AVAILABLE INFORMATION, THERE IS NO INDICATION THAT THE COMPLAINT LED 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 03 JUNE 2024. IT WAS REPORTED BY HAMILTON MEDICAL INC, THAT ON 31 MAY 2024 DURING PREVENTIVE MAINTENANCE, A HAMILTON T1 VENTILATOR (SN (B)(6)) FAILED DURING FLOW TEST. NEED TO ORDER CHECK VALVE ASSEMBLY. ACCORDING TO THE PRELIMINARY INVESTIGATION PERFORMED, POTENTIAL ROOT CAUSE ASSOCIATED TO THE REPORTED ISSUE ARE AS FOLLOW: EXTERNAL DEVICE IS SET TO STLD INSTEAD OF ATP; EXTERNAL FS NOT CALIBRATED; DEFECTIVE EXTERNAL FS; LEAK (E.G OBSTRUCTION VALVE, TUBING, FS); RINSE FLOW ASYMMETRIC; OSCILLATION, TURBULENCE BEFORE QVENT SENSOR (1ST GENERATION); DEFECTIVE QVENT SENSOR; PFLOW SENSOR DEFECT, AZ LEAKAGE (PRESSURE SENSOR ASSEMBLY). THE FOLLOWING CORRECTION CAN BE CONSIDERED ACCORDINGLY: MAKE SURE THE EXTERNAL MEASUREMENT IS SET TO ATP. IF QVENT DOES NOT MATCH THE EXTERNAL MEASUREMENT THEN: CHECK FOR LEAKS (CHECK OBSTRUCTION VALVE); INSTALL FLOW MESH MSP161944 (1ST GEN HW ONLY, SEE KB-ID 3145); REPLACE QVENT IF PROBLEM REMAINS. IF QVENT MATCHS EXTERNAL MEASUREMENT , BUT QAW IS OUT OF RANGE, THEN: CHECK EXPIRATORY VALVE / MEMBRANE COVER IF PROPERLY SEATED; CHECK BREATHING CIRCUIT FOR LEAK; CALIBRATE FLOW SENSOR; CHECK RINSE FLOW; REPLACE FLOW SENSOR. REPORTEDLY, THERE NO PATIENT INVOLVED. ACCORDING TO THE AVAILABLE 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
    2206344 HAMILTON-T1 HAMILTON-T1 CBK HAMILTON MEDICAL AG 161006 07630002801850

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown