BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAMILTON-T1

    MDR report key: 18353486 · Received December 19, 2023

    Report

    Report Number
    3001421318-2023-04261
    Event Type
    Injury
    Date Received
    December 19, 2023
    Date of Event
    November 11, 2023
    Report Date
    November 11, 2025
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002813532
    PMA / PMN Number
    K181216
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG CASE NUMBER IS CER (B)(4). INVESTIGATION ONGOING. HAMILTON MEDICAL AG COMPLAINT NUMBER: CER (B)(4). FOLLOW-UP 1 - CORRECTED INFORMATION: **UDI RELATED DATA QUALITY UPDATES ONLY** FIELD D4 WAS UPDATED WITH FULL UDI INFORMATION AS REQUESTED.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: THIS EVENT WAS REPORTED TO HAMILTON AS VENTILATOR DEVICE HAVING ISSUES WITH THE OXYGEN-DELIVERY. THIS OCCURRENCE WAS NOTICED DURING PATIENT VENTILATION. THE VENTILATOR DEVICE WAS USED ON A INTUBATED PATIENT. VARIOUS ALARMS WERE OBSERVABLE BOTH VISUALLY AND THROUGH HEARING. PA 141009 (OXYGENLOW) AND TE 231006 (O2 CONTROLLER FLOW LOW). THE VENTILATOR DEVICE WAS PLUGGED ON WALL OXYGEN. THE DEVICE LOG FILES WERE PROVIDED TO HAMILTON. THIS EVENT OCCURRED DURING VENTILATION BUT WAS NOT FURTHER CLARIFIED. THERE IS NEED FOR MEDICAL INTERVENTION REPORTED. A SECOND VENTILATOR ON PORTABLE TANK HAD TO BE USED ON PATIENT. PATIENT HARM WAS REPORTED, BUT FURTHER EXPLANATION ABOUT THE HARM WAS NOT REPORTED TO HAMILTON. NEITHER DELAY IN TREATMENT NOR HARM TO THE 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: - THIS EVENT WAS REPORTED TO HAMILTON AS VENTILATOR DEVICE HAVING ISSUES WITH THE OXYGEN-DELIVERY. - THIS OCCURRENCE WAS NOTICED DURING PATIENT VENTILATION. THE VENTILATOR DEVICE WAS USED ON A INTUBATED PATIENT. - VARIOUS ALARMS WERE OBSERVABLE BOTH VISUALLY AND THROUGH HEARING. PA 141009 (OXYGENLOW) AND TE 231006 (O2CONTROLLERFLOWLOW). THE VENTILATOR DEVICE WAS PLUGGED ON WALL OXYGEN. - THE DEVICE LOG FILES WERE PROVIDED TO HAMILTON. - THIS EVENT OCCURRED DURING VENTILATION BUT WAS NOT FURTHER CLARIFIED. - THERE IS NEED FOR MEDICAL INTERVENTION REPORTED. A SECOND VENTILATOR ON PORTABLE TANK HAD TO BE USED ON PATIENT. - PATIENT HARM WAS REPORTED, BUT FURTHER EXPLANATION ABOUT THE HARM WAS NOT REPORTED TO HAMILTON. - NEITHER DELAY IN TREATMENT NOR HARM TO THE USER OR THIRD PARTY HAS BEEN REPORTED. THE INVESTIGATION IS STILL ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    928899 HAMILTON-T1 HAMILTON-T1 CBK HAMILTON MEDICAL AG 161006 07630002813532

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other