BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-C6

    MDR report key: 23797517 · Received December 13, 2025

    Report

    Report Number
    3001421318-2025-00971
    Event Type
    Malfunction
    Date Received
    December 13, 2025
    Date of Event
    November 20, 2025
    Report Date
    December 13, 2025
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002808590
    PMA / PMN Number
    K201658
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG REF. NR: (B)(4); HAMILTON MEDICAL AGS CONCLUSION: THE ON-SITE HAMILTON MEDICAL INC. SERVICE TECHNICIAN CONFIRMED THAT THE DEVICE DISPLAY WENT BLACK WHILE CONNECTED TO A PATIENT. LOG FILE ANALYSIS VERIFIED THE EVENT, SHOWING THE ENTRIES ¿PANEL CONNECTION LOST¿ AND ¿PANEL RECONNECTED.¿ TO ADDRESS THE ISSUE, THE TECHNICIAN REPORTED THAT BOTH THE PROCESSOR BOARD AND THE VU ESM BOARD ARE BEING REPLACED.

    Description of Event or Problem · 0

    HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: CUSTOMER REPORTS DISPLAY WENT BLACK WHILE ON A PATIENT. AN ADDITIONAL DEVICE WAS REQUIRED. NO FURTHER CLINICAL SIGNS, SYMPTOMS OR CONDITIONS AND NO HEALTH CONSEQUENCES OR IMPACT, WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2762227 HAMILTON-C6 HAMILTON-C6 CBK HAMILTON MEDICAL AG 160021 07630002808590

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown