BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-T1

    MDR report key: 18856457 · Received March 7, 2024

    Report

    Report Number
    3001421318-2024-00534
    Event Type
    Malfunction
    Date Received
    March 7, 2024
    Date of Event
    August 15, 2023
    Report Date
    September 29, 2025
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    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.   UPDATED FIELDS: B4, D1, D3, D4, G6, H2, H4, H11.

    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: FOLLOW-UP 2 - ADDITIONAL INFORMATION: THE ENTRY FIELDS HAVE BEEN UPDATED. THE ROOT CAUSE OF THE EVENT WAS DETERMINED TO BE A DEFECTIVE PRESSURE SENSOR ASSEMBLY. AFTER REPLACING THE PRESSURE SENSOR ASSEMBLY, THE DEVICE WAS RELEASED BACK INTO USE.

    Description of Event or Problem · 0

    THE FOLLOWING HAS BEEN REPORTED TO HAMILTON MEDICAL AG ON FEBRUARY 02ND 2024. CUSTOMER REPORTS, DURING START-UP, FLOW SENSOR AND EXHALATION VALVE COULD NOT CALIBRATE. DEVICE REPEATEDLY FAILED 'FLOW SENSOR CALIBRATION' IN PRE-OPP CHECK. LATER, IT ALARMED FOR 'TE233002' AND FAILED THE SELF TEST AT START-UP. IT ALSO FAILED MULTIPLE TESTS RELATED TO PRESSURE SENSOR ASSEMBLY IN SERVICE SOFTWARE, INCLUDING 'BINARY VALVE TESTS' AND 'AUTOZERO TESTS'. DEVICE ALARMS WITH LOW PRIORITY ALARM 233002 (PVENT_CONTROL AUTOZERO FAILED) AND "TECHNICAL EVENT: 233005" (PRESSURE SENSOR TOLERANCE). AS A TROUBLOSHOOTING PROVIDED BY HAMILTON TECHNICAL SUPPORT, THE PRESSURE SENSOR ASSEMBLY WAS REPLACED. NO INDICATION THAT THE COMPLAINT LEAD TO DEATH, INJURY OR SERIOUS DETERIORATION OF THE HEALTH OF THE PATIENT, USER OR THIRD-PARTY. ACCORDING TO PRELIMINARY ANALYSIS, PRESSURE SENSOR OUT OF TOLERANCE AFTER AUTOZEROING PROCEDURE DUE TO: -DEFECTIVE AUTOZERO VALVE PVENT_MONITOR, -DEFECTIVE PRESSURE SENSOR PVENT_MONITOR/PVENT_CONTROL, AND -LEAKAGE IN PRESSURE SENSOR ASSEMBLY.

    Description of Event or Problem · 0

    THE FOLLOWING HAS BEEN REPORTED TO HAMILTON MEDICAL AG ON FEBRUARY 02ND 2024 CUSTOMER REPORTS, DURING START-UP, FLOW SENSOR AND EXHALATION VALVE COULD NOT CALIBRATE. DEVICE REPEATEDLY FAILED 'FLOW SENSOR CALIBRATION' IN PRE-OPP CHECK. LATER, IT ALARMED FOR 'TE233002' AND FAILED THE SELF TEST AT START-UP. IT ALSO FAILED MULTIPLE TESTS RELATED TO PRESSURE SENSOR ASSEMBLY IN SERVICE SOFTWARE, INCLUDING 'BINARY VALVE TESTS' AND 'AUTOZERO TESTS'. DEVICE ALARMS WITH LOW PRIORITY ALARM 233002 (PVENT_CONTROL AUTOZERO FAILED) AND "TECHNICAL EVENT: 233005" (PRESSURE SENSOR TOLERANCE). AS A TROUBLOSHOOTING PROVIDED BY HAMILTON TECHNICAL SUPPORT, THE PRESSURE SENSOR ASSEMBLY WAS REPLACED. NO INDICATION THAT THE COMPLAINT LEAD TO DEATH, INJURY OR SERIOUS DETERIORATION OF THE HEALTH OF THE PATIENT, USER OR THIRD-PARTY. ACCORDING TO PRELIMINARY ANALYSIS, PRESSURE SENSOR OUT OF TOLERANCE AFTER AUTOZEROING PROCEDURE DUE TO: DEFECTIVE AUTOZERO VALVE PVENT_MONITOR, DEFECTIVE PRESSURE SENSOR PVENT_MONITOR/PVENT_CONTROL, LEAKAGE IN PRESSURE SENSOR ASSEMBLY.

    Description of Event or Problem · 0

    THE FOLLOWING HAS BEEN REPORTED TO HAMILTON MEDICAL AG ON FEBRUARY 02ND 2024. CUSTOMER REPORTS, DURING START-UP, FLOW SENSOR AND EXHALATION VALVE COULD NOT CALIBRATE. DEVICE REPEATEDLY FAILED 'FLOW SENSOR CALIBRATION' IN PRE-OPP CHECK. LATER, IT ALARMED FOR 'TE233002' AND FAILED THE SELF TEST AT START-UP. IT ALSO FAILED MULTIPLE TESTS RELATED TO PRESSURE SENSOR ASSEMBLY IN SERVICE SOFTWARE, INCLUDING 'BINARY VALVE TESTS' AND 'AUTOZERO TESTS'. DEVICE ALARMS WITH LOW PRIORITY ALARM 233002 (PVENT_CONTROL AUTOZERO FAILED) AND "TECHNICAL EVENT: 233005" (PRESSURE SENSOR TOLERANCE). AS A TROUBLOSHOOTING PROVIDED BY HAMILTON TECHNICAL SUPPORT, THE PRESSURE SENSOR ASSEMBLY WAS REPLACED. NO INDICATION THAT THE COMPLAINT LEAD TO DEATH, INJURY OR SERIOUS DETERIORATION OF THE HEALTH OF THE PATIENT, USER OR THIRD-PARTY. ACCORDING TO PRELIMINARY ANALYSIS, PRESSURE SENSOR OUT OF TOLERANCE AFTER AUTOZEROING PROCEDURE DUE TO: DEFECTIVE AUTOZERO VALVE PVENT_MONITOR DEFECTIVE PRESSURE SENSOR PVENT_MONITOR/PVENT_CONTROL LEAKAGE IN PRESSURE SENSOR ASSEMBLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1976549 HAMILTON-T1 HAMILTON-T1 CBK HAMILTON MEDICAL AG 161006

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown