BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-T1

    MDR report key: 19640337 · Received June 29, 2024

    Report

    Report Number
    3001421318-2024-01557
    Event Type
    Malfunction
    Date Received
    June 29, 2024
    Date of Event
    May 23, 2024
    Report Date
    November 3, 2025
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002801850
    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.

    Description of Event or Problem · 0

    THE FOLLOWING HAS BEEN REPORTED TO HAMILTON MEDICAL AG ON 28 MAY 2024 IT WAS REPORTED BY HAMILTON MEDICAL INC, THAT ON 23 MAY 2024, A HAMILTON T1 VENTILATOR (SN (B)(6)) FAILED TO TURN-ON. THE DISPLAY OR THE DEVICE REMAINS DARK AND IT SHOWS NO VISUAL OR AUDIBLE ALARM. ACCORDING TO THE PRELIMINARY INVESTIGATION PERFORMED, POTENTIAL ROOT CAUSE ASSOCIATED TO THE REPORTED ISSUE ARE AS FOLLOW: -DEFECTIVE ESM. -DEFECTIVE DRIVER BOARD. -DEFECTIVE CONTROL BOARD. -DEFECTIVE FRONT PANEL BOARD. THE FOLLOWING CORRECTION CAN BE CONSIDERED ACCORDINGLY: - ENSURE CABLE CONNECTIONS BETWEEN DRIVER BOARD AND CONTROL BOARD ARE PROPERLY CONNECTED. - ENSURE FFC BETWEEN CONTROL BOARD AND FRONT PANEL BOARD IS PROPERLY CONNECTED AND IN GOOD CONDITION. - CHECK VOLTAGES AT VOLTAGE TEST POINT P5 ON CONTROL BOARD. - REPLACE DEFECTIVE COMPONENT. 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 28 MAY 2024. IT WAS REPORTED, BY HAMILTON MEDICAL INC. THAT ON 23 MAY 2024, A HAMILTON T1 VENTILATOR (SN (B)(6)) FAILED TO TURN-ON. THE DISPLAY OR THE DEVICE REMAINS DARK. AND IT SHOWS NO VISUAL OR AUDIBLE ALARM. ACCORDING TO THE PRELIMINARY INVESTIGATION PERFORMED, POTENTIAL ROOT CAUSE ASSOCIATED TO THE REPORTED ISSUE ARE AS FOLLOW: DEFECTIVE ESM, DEFECTIVE DRIVER BOARD, DEFECTIVE CONTROL BOARD, DEFECTIVE FRONT PANEL BOARD THE FOLLOWING CORRECTION CAN BE CONSIDERED ACCORDINGLY: ENSURE CABLE CONNECTIONS BETWEEN DRIVER BOARD AND CONTROL BOARD ARE PROPERLY CONNECTED. ENSURE FFC BETWEEN CONTROL BOARD AND FRONT PANEL BOARD IS PROPERLY CONNECTED AND IN GOOD CONDITION. CHECK VOLTAGES AT VOLTAGE TEST POINT P5 ON CONTROL BOARD. REPLACE DEFECTIVE COMPONENT. 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
    851592 HAMILTON-T1 HAMILTON-T1 CBK HAMILTON MEDICAL AG 161006 07630002801850

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown