BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-T1

    MDR report key: 20628460 · Received November 7, 2024

    Report

    Report Number
    3001421318-2024-02661
    Event Type
    Malfunction
    Date Received
    November 7, 2024
    Date of Event
    October 25, 2024
    Report Date
    November 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
    ES
    Reporter Occupation
    505

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG EVENT REFERENCE NUMBER: (B)(4). THE INTERNAL PRODUCT INVESTIGATION IS STILL ONGOING. AS SOON AS THE RESULTS ARE AVAILABLE, THE MANUFACTURER WILL SUBMIT AN UPDATE OF THIS REPORT UNSOLICITED.

    Description of Event or Problem · 0

    THE EVENT DESCRIPTION ACCORDING TO THE CUSTOMER IS AS FOLLOWS: ALARM "LOSS OF EXTERNAL POWER" WAS DISPLAYED ON SCREEN. BATTERY IS NOT BEING CHARGED.IT WAS MEASURED THE INPUT VOLTAGE DIRECTLY FROM THE A/C SOCKET OF THE WALL, AND AT THE END OF THE POWER CORD, AND THE EQUIPMENT IS RECEIVING 120VAC. POWER SUPPLY IS NOT WORKING, INDICATOR LED OF POWER/STANDBY KEY REMAINS PERMANENTLY OFF WHEN THE EQUIPMENT IS CONNECTED TO THE A/C SOCKET OF THE WALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1429695 HAMILTON-T1 HAMILTON-T1 CBK HAMILTON MEDICAL AG 161006 07630002801850

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown