BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-C6

    MDR report key: 18146511 · Received November 16, 2023

    Report

    Report Number
    3001421318-2023-03875
    Event Type
    Malfunction
    Date Received
    November 16, 2023
    Date of Event
    September 4, 2023
    Report Date
    August 16, 2024
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002808590
    PMA / PMN Number
    K201658
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG COMES TO THE CONCLUSION: FSN WAS INITIATED: Z-0267-2023 (SEPTEMBER 22, 2022): IN VERY RARE CASES, THE BACKLIGHT OF THE HAMILTON-C6 DISPLAY MAY FAIL. THIS IS ATTRIBUTABLE TO A RESET OF THE HMI CONTROLLER (HMI RESET) WHICH CAUSES THE DISPLAY TO FAIL FOR 2-3 SECONDS. THE DEVICE'S VENTILATION FUNCTION IS NOT AFFECTED BY THIS.

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG COMES TO THE CONCLUSION: FSN WAS INITIATED: Z-0267-2023 (B)(6) 2022: IN VERY RARE CASES, THE BACKLIGHT OF THE HAMILTON-C6 DISPLAY MAY FAIL. THIS IS ATTRIBUTABLE TO A RESET OF THE HMI CONTROLLER (HMI RESET) WHICH CAUSES THE DISPLAY TO FAIL FOR 2-3 SECONDS. THE DEVICE'S VENTILATION FUNCTION IS NOT AFFECTED BY THIS. HAMILTON MEDICAL AG COMPLAINT NUMBER: CER (B)(4). FOLLOW-UP 1 - CORRECTED INFORMATION: **UDI RELATED DATA QUALITY UPDATES ONLY** FIELD D4 WAS UPDATED WITH FULL UDI INFORMATION AS REQUESTED.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: INTERACTION PANEL BLACKOUT FOR 2-3 SEC (HMI RESET).

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: INTERACTION PANEL BLACKOUT FOR 2-3 SEC (HMI RESET).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2239578 HAMILTON-C6 HAMILTON-C6 CBK HAMILTON MEDICAL AG 160021 07630002808590

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown