BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-T1

    MDR report key: 17938271 · Received October 16, 2023

    Report

    Report Number
    3001421318-2023-03535
    Event Type
    Malfunction
    Date Received
    October 16, 2023
    Date of Event
    July 5, 2023
    Report Date
    August 7, 2024
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002801850
    PMA / PMN Number
    K181216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION ONGOING. HAMILTON MEDICAL AG COMPLAINT NUMBER: (B)(4). FOLLOW-UP 1 - CORRECTED INFORMATION: **UDI RELATED DATA QUALITY UPDATES ONLY**

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG CASE NUMBER IS CER (B)(4). INVESTIGATION ONGOING.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: THE FLOW SENSOR AND O2 CALIBRATIONS FAILED, AND SEVERAL ALARMS WERE ACTIVATED. THESE MALFUNCTIONS OCCURRED DURING PATIENT VENTILATION AND DURING STARTUP AND IN STANDBY MODE. VARIOUS ALARMS WERE OBSERVABLE BOTH VISUALLY AND THROUGH HEARING. O2VALVELEAK (ID 231008, TAGD_O2VALVELEAK), O2CONTROLLERFLOWHIGH (ID 231007, TAGD_O2CONTROLLERFLOWHIGH) VT LOW (ID 141003, PAVMC_VTLOW), LOW MINUTE VOLUME ( ID 141005, PAVMC_EXPMINVOLLOW), LOSS OF PEEP (ID 141052, PAVMC_PEEPLOW), LOW PRESSURE (ID 141024, PAVMC_PRESSURELOW), LOW OXYGEN (ID 141009 PAVMC_OXYGENLOW), OXYGEN SUPPLY FAILED (ID 231006, TAGD_O2CONTROLLERFLOWLOW). THE O2 INPUT FLOW TEST FAILED WHILE RUNNING THE SERVICE SOFTWARE. THESE MALFUNCTIONS WERE REPRODUCIBLE. THERE WAS PATIENT INVOLVEMENT REPORTED BECAUSE THE EVENT ALSO AS IS BEING SAID OCCURRED DURING VENTILATION, BUT THIS WAS NOT FURTHER EXPLAINED. THERE WAS NO NEED FOR ANY MEDICAL INTERVENTION REPORTED. NEITHER DELAY IN TREATMENT NOR HARM TO THE PATIENT, USER OR THIRD PARTY HAS BEEN REPORTED. THE INVESTIGATION IS STILL ONGOING.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: · THE FLOW SENSOR AND O2 CALIBRATIONS FAILED, AND SEVERAL ALARMS WERE ACTIVATED. · THESE MALFUNCTIONS OCCURRED DURING PATIENT VENTILATION AND DURING STARTUP AND IN STANDBY MODE. · VARIOUS ALARMS WERE OBSERVABLE BOTH VISUALLY AND THROUGH HEARING. O2VALVELEAK (ID (B)(6). TAGD_O2VALVELEAK), O2CONTROLLERFLOWHIGH (ID (B)(6), TAGD_O2CONTROLLERFLOWHIGH) VT LOW (ID (B)(6) , PAVMC_VTLOW), LOW MINUTE VOLUME ( ID (B)(6), PAVMC_EXPMINVOLLOW), LOSS OF PEEP (ID (B)(6) , PAVMC_PEEPLOW), LOW PRESSURE (ID (B)(6) , PAVMC_PRESSURELOW), LOW OXYGEN (ID (B)(6) PAVMC_OXYGENLOW), OXYGEN SUPPLY FAILED (ID (B)(6), TAGD_O2CONTROLLERFLOWLOW). THE O2 INPUT FLOW TEST FAILED WHILE RUNNING THE SERVICE SOFTWARE. · THESE MALFUNCTIONS WERE REPRODUCIBLE. - THERE WAS PATIENT INVOLVEMENT REPORTED BECAUSE THE EVENT ALSO AS IS BEING SAID OCCURRED DURING VENTILATION, BUT THIS WAS NOT FURTHER EXPLAINED. · THERE WAS NO NEED FOR ANY MEDICAL INTERVENTION REPORTED. · NEITHER DELAY IN TREATMENT NOR HARM TO THE PATIENT, USER OR THIRD PARTY HAS BEEN REPORTED. THE INVESTIGATION IS STILL ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2120672 HAMILTON-T1 HAMILTON-T1 CBK HAMILTON MEDICAL AG 161006 07630002801850

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown