BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-T1

    MDR report key: 19404730 · Received May 28, 2024

    Report

    Report Number
    3001421318-2024-01318
    Event Type
    Malfunction
    Date Received
    May 28, 2024
    Date of Event
    May 2, 2024
    Report Date
    November 14, 2025
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002801850
    PMA / PMN Number
    K181216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG CASE NUMBER IS (B)(4). INVESTIGATION ONGOING. HAMILTON MEDICAL AG COMPLAINT NUMBER: (B)(4). FOLLOW-UP 1 - CORRECTED INFORMATION: FIELD D4 WAS UPDATED WITH FULL UDI INFORMATION. UPDATED FIELDS: B4, D1, D4, G6, H2, H4, H11.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: THIS EVENT WAS REPORTED TO HAMILTON MEDICAL AG AS, VENTILATOR DEVICE ALARMED AND FAILED FOR STARTUP. BLACK SCREEN. WHEN THIS WAS NOTICED, THE VENTILATOR WAS NOT IN USE TO VENTILATE A PATIENT. IT OCCURRED DURING STARTUP BIS IS NOT FURTHER SPECIFIED. NO FURTHER DETAILS ABOUT WHEN THIS HAPPENED WERE REPORTED TO HAMILTON MEDICAL AG. THE HAMILTON VIGILANCE REPORTING DECISION STRATEGY PRESCRIBES TO REPORT STARTUP ISSUES. AN ALARM WAS TRIGGERED. NO FURTHER DETAILS ABOUT THE ALARM WAS REPORTED TO HAMILTON MEDICAL AG. THE INSTRUMENT REPORT AND THE DEVICE LOG FILE'S (SERVICE LOG, ERROR LOG, EVENT LOG) WERE NOT PROVIDED TO HAMILTON MEDICAL AG. THIS MALFUNCTIONING WAS REPRODUCIBLE. THERE IS NO PATIENT INVOLVEMENT REPORTED. THERE IS 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: THIS EVENT WAS REPORTED TO HAMILTON MEDICAL AG AS, VENTILATOR DEVICE ALARMED AND FAILED FOR STARTUP. BLACK SCREEN. WHEN THIS WAS NOTICED, THE VENTILATOR WAS NOT IN USE TO VENTILATE A PATIENT. IT OCCURRED DURING STARTUP BIS IS NOT FURTHER SPECIFIED. NO FURTHER DETAILS ABOUT WHEN THIS HAPPENED WERE REPORTED TO HAMILTON MEDICAL AG. THE HAMILTON VIGILANCE REPORTING DECISION STRATEGY PRESCRIBES TO REPORT STARTUP ISSUES. AN ALARM WAS TRIGGERED. NO FURTHER DETAILS ABOUT THE ALARM WAS REPORTED TO HAMILTON MEDICAL AG. THE INSTRUMENT REPORT AND THE DEVICE LOG FILE'S (SERVICE LOG, ERROR LOG, EVENT LOG) WERE NOT PROVIDED TO HAMILTON MEDICAL AG. THIS MALFUNCTIONING WAS REPRODUCIBLE. THERE IS NO PATIENT INVOLVEMENT REPORTED. THERE IS 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
    688542 HAMILTON-T1 HAMILTON-T1 CBK HAMILTON MEDICAL AG 161006 07630002801850

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown