BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-C3

    MDR report key: 21312000 · Received February 5, 2025

    Report

    Report Number
    3001421318-2025-00225
    Event Type
    Malfunction
    Date Received
    February 5, 2025
    Date of Event
    January 2, 2025
    Report Date
    December 8, 2025
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    PMA / PMN Number
    K201306
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG`S CONCLUSION: INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AGS REF. (B)(4); HAMILTON MEDICAL AGS CONCLUSION: HAMILTON MEDICAL AG HAS NOT RECEIVED THE HAMILTON-C3 OR THE POWER SUPPLY FOR INVESTIGATION. NO FURTHER INFORMATION HAS BEEN RECEIVED. HOWEVER, IT WAS CONFIRMED FROM HAMILTON MEDICAL INC. THAT A NEW POWER SUPPLY WAS DELIVERED TO THE CUSTOMER, AND THE DEVICE IS RETURNED TO SERVICE.

    Description of Event or Problem · 0

    COMPLAINT DESCRIPTION QUOTATION OF THE CUSTOMER/REPORTER: "EXTERNAL POWER ERROR."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52939 HAMILTON-C3 HAMILTON-C3 CBK HAMILTON MEDICAL AG 160005

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown