BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-C1

    MDR report key: 20382890 · Received October 7, 2024

    Report

    Report Number
    3001421318-2024-02406
    Event Type
    Malfunction
    Date Received
    October 7, 2024
    Date of Event
    April 16, 2024
    Report Date
    October 7, 2024
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002813426
    PMA / PMN Number
    K181216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG CASE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: THE DEVICE IS NOT POWERING ON, THE LED AC INDICATOR IN NOT ON. WE CHECKED AC CABLE, AC SOURSE AND IT WERE OK, WE DESSASEMBLY THE DEVICE AND REPLACED POWER SUPPLY AND THE DEVICE POWER ON NORMALLY. THE POWER SUPPLY IS DAMAGE, WE COULD NOTICE THE BOARD IS BURNED. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2547204 HAMILTON-C1 HAMILTON-C1 CBK HAMILTON MEDICAL AG 1610010 07630002813426

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown