BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-T1

    MDR report key: 19640355 · Received June 29, 2024

    Report

    Report Number
    3001421318-2024-01559
    Event Type
    Malfunction
    Date Received
    June 29, 2024
    Date of Event
    July 27, 2023
    Report Date
    November 17, 2025
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002813532
    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).

    Description of Event or Problem · 0

    THE FOLLOWING HAS BEEN REPORTED TO HAMILTON MEDICAL AG ON (B)(6)2024 IT WAS REPORTED BY HAMILTON MEDICAL INC, THAT ON (B)(6)2024 DURING TESTING, A HAMILTON T1 VENTILATOR (SN (B)(6)) ALARMS FOR TE244021 AT START-UP BOTH ON AC AND ON BATTERY. VENTILATOR DISPLAYED TF: 244021, USUALLY MID FLIGHT FOR EMS COMPANY. THIS CODE SHOWS UP WHETHER THE VENT IS ON BATTERY, OR AC POWER. I HAD THE TECH SWAP BATTERIES, CONFIRM CHARGING LIGHTS, RESEAT THE BATTERIES AND HE RECONDITIONED ONE WITH THE SOH LOWER THAN WHEN HE STARTED. THEY ARE USING A SINE WAVE OUTPUT (NOT MODIFIED). ACCORDING TO THE PRELIMINARY INVESTIGATION PERFORMED, POTENTIAL ROOT CAUSE ASSOCIATED TO THE REPORTED ISSUE ARE AS FOLLOW: -DEFECTIVE BATTERY -DEFECTIVE POWER SUPPLY -DEFECTIVE BATTERY CONNECTOR BOARD THE FOLLOWING CORRECTION CAN BE CONSIDERED ACCORDINGLY: -REMOVE BATTERY ONE AT A TIME AND OBSERVE IF THE ERROR PERMANENTLY DISAPPEARS. -CROSS CHECK ON OTHER DEVICE WITH THE SAME SW VERSION, IF THE ERROR REPLICATES. -REPLACE THE DEFECTIVE BATTERY. -REPLACE POWER SUPPLY, IF THE ISSUE PERSIST. -REPLACE BATTERY CONNECTOR BOARD 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.

    Description of Event or Problem · 0

    THE FOLLOWING HAS BEEN REPORTED TO HAMILTON MEDICAL AG ON 30 MAY 2024 IT WAS REPORTED BY HAMILTON MEDICAL INC, THAT ON 23 MAY 2024 DURING TESTING, A HAMILTON T1 VENTILATOR (SN (B)(6)) ALARMS FOR TE244021 AT START-UP BOTH ON AC AND ON BATTERY. VENTILATOR DISPLAYED TF: 244021, USUALLY MID FLIGHT FOR EMS COMPANY. THIS CODE SHOWS UP WHETHER THE VENT IS ON BATTERY, OR AC POWER. I HAD THE TECH SWAP BATTERIES, CONFIRM CHARGING LIGHTS, RESEAT THE BATTERIES AND HE RECONDITIONED ONE WITH THE SOH LOWER THAN WHEN HE STARTED. THEY ARE USING A SINE WAVE OUTPUT (NOT MODIFIED). ACCORDING TO THE PRELIMINARY INVESTIGATION PERFORMED, POTENTIAL ROOT CAUSE ASSOCIATED TO THE REPORTED ISSUE ARE AS FOLLOW: DEFECTIVE BATTERY; DEFECTIVE POWER SUPPLY; DEFECTIVE BATTERY CONNECTOR BOARD. THE FOLLOWING CORRECTION CAN BE CONSIDERED ACCORDINGLY: REMOVE BATTERY ONE AT A TIME AND OBSERVE IF THE ERROR PERMANENTLY DISAPPEARS. CROSS CHECK ON OTHER DEVICE WITH THE SAME SW VERSION, IF THE ERROR REPLICATES. REPLACE THE DEFECTIVE BATTERY. REPLACE POWER SUPPLY, IF THE ISSUE PERSIST. REPLACE BATTERY CONNECTOR BOARD. 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
    2174805 HAMILTON-T1 HAMILTON-T1 CBK HAMILTON MEDICAL AG 1610060 07630002813532

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown