BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-C3

    MDR report key: 21239992 · Received January 27, 2025

    Report

    Report Number
    3001421318-2025-00167
    Event Type
    Malfunction
    Date Received
    January 27, 2025
    Date of Event
    January 17, 2025
    Report Date
    January 27, 2025
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002801881
    PMA / PMN Number
    K201306
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AGS CONCLUSION: THE ROOT CAUSE WAS ATTRIBUTED TO A DEFECTIVE MAINBOARD. THE CORRECTION CONSISTED IN THE EXCHANGE OF THE MAINBOARD.

    Description of Event or Problem · 0

    SELF-TEST FAILED, 431008, 231012, 231023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533343 HAMILTON-C3 HAMILTON-C3 CBK HAMILTON MEDICAL AG 160005 07630002801881

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown