BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 17215984 · Received June 28, 2023

    Report

    Report Number
    3001421318-2023-02464
    Event Type
    Malfunction
    Date Received
    June 28, 2023
    Date of Event
    June 2, 2023
    Report Date
    July 2, 2025
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002813549
    PMA / PMN Number
    K181216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    505

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG CASE NUMBER IS (B)(4). FOLLOW-UP 1 - ADDITIONAL INFORMATION: FIELDS B4, G6, H2, H3, H6 AND H11 ARE UPDATED. AN ISSUE ABOUT A CONNECTION WITH THE USE OF A NEWLY INSTALLED LCD WAS REPORTED. THE IMAGE ON THE DISPLAY APPEARED DARK AND FUZZY WITH A DOUBLE IMAGE WHEN VIEWED DIRECTLY BUT WAS CLEAR WHEN VIEWED FROM THE SIDE OR WHEN THE LCD WAS ROTATED 90 DEGREES BEHIND THE TOUCHSCREEN. THE ISSUE WAS REPRODUCIBLE THE ISSUE WAS NOTICED WITH NO PATIENT'S INVOLVEMENT. CONSEQUENTLY, THE EVENT DID NOT CAUSE OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY OF A PATIENT. THE ISSUE WAS RELATED TO HARDWARE COMPATIBILITY BETWEEN THE NEWLY INSTALLED LCD AND THE FRONT PANEL BOARD. THE LCD WAS INTRODUCED AS A REPLACEMENT FOR A DISCONTINUED MODEL. ACCORDING TO TECHNICAL DOCUMENTATION, THE NEW LCD REQUIRES A SPECIFIC FRONT PANEL BOARD REVISION AND CORRECT JUMPER SETTINGS. THE DISPLAY WAS REPLACED, AND THE DEVICE WAS REPORTED TO BE FUNCTIONING CORRECTLY. NO FURTHER INFORMATION OR LOG FILES WERE PROVIDED BY THE CUSTOMER DESPITE 3 REMINDERS ((B)(6) 2023) . THE CASE WAS CLOSED. THIS SPECIFIC CASE DID NOT DELIVER ANY INFORMATION ABOUT A MALFUNCTION OF THE DEVICE COMBINED WITH THE FACT THAT THE DEVICE OR A SIMILAR DEVICE WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR. IN AGREEMENT WITH THE FDA, UDI NUMBERS (FIELD D4 IN THIS FORM) ARE ONLY PROVIDED FOR INCIDENTS THAT HAVE BEEN INITIALLY REPORTED BY HAMILTON MEDICAL AG SINCE OCTOBER 1ST, 2023.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: DISPLAY LCD MODEL NL6448BC-26-22F (380033) REPLACED BY MODEL: NL6448BC26-26F (380051) DUE TO DISCONTINUATION OF LCD MODEL NL6448BC-26-22F (380033). 1. WHEN WE LOOK DIRECTLY AT THE DISPLAY. THE PICTURE IS DARK, PLUS ITS LOOKS FUZZY WITH A DOUBLE IMAGE. 2. LOOKING FROM THE SIDE, IT IS CLEAR. 3. IF WE TURN THE LCD 90 DEGREES BEHIND THE TOUCHSCREEN, THE DISPLAY IS CLEAR. STILL UNDER INVESTIGATION. NO PATIENT INVOLVED.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: DISPLAY LCD MODEL NL6448BC-26-22F (380033) REPLACED BY MODEL: NL6448BC26-26F (380051) DUE TO DISCONTINUATION OF LCD MODEL NL6448BC-26-22F (380033). 1. WHEN WE LOOK DIRECTLY AT THE DISPLAY. THE PICTURE IS DARK, PLUS ITS LOOKS FUZZY WITH A DOUBLE IMAGE. 2. LOOKING FROM THE SIDE, IT IS CLEAR. 3. IF WE TURN THE LCD 90 DEGREES BEHIND THE TOUCHSCREEN, THE DISPLAY IS CLEAR. STILL UNDER INVESTIGATION. NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148036 HAMILTON MEDICAL AG HAMILTON-T1 CBK HAMILTON MEDICAL AG HAMILTON-T1 07630002813549

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown