BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-C1

    MDR report key: 18612044 · Received January 31, 2024

    Report

    Report Number
    3001421318-2024-00254
    Event Type
    Malfunction
    Date Received
    January 31, 2024
    Date of Event
    January 8, 2024
    Report Date
    October 18, 2024
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002800747
    PMA / PMN Number
    K181216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG CASE NUMBER IS: (B)(4). FOLLOW-UP 1 - CORRECTED INFORMATION: FIELD D4 WAS UPDATED WITH FULL UDI INFORMATION. UPDATED FIELDS: B4, D1, D4, G6, H2, H4, H11.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: DURING TESTS: BLACK SCREEN. BECAUSE THE UNIT CAN'T BE TURNED ON, I COULDN'T DO ALL THE TESTS.DEFECTIVE DRIVER BOARD.REPLACE DRIVER BOARD, IT'S OK. BURNING SMELL, TEST THE OUTPUT VOLTAGE TO DETERMINE THE FAULT OF THE POWER SUPPLY. REPLACE POWER SUPPLY, IT'S OK. NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: DURING TESTS: BLACK SCREEN. BECAUSE THE UNIT CAN'T BE TURNED ON, I COULDN'T DO ALL THE TESTS. DEFECTIVE DRIVER BOARD. REPLACE DRIVER BOARD, IT'S OK. BURNING SMELL,TEST THE OUTPUT VOLTAGE TO DETERMINE THE FAULT OF THE POWER SUPPLY .REPLACE POWER SUPPLY, IT'S OK. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1261751 HAMILTON-C1 HAMILTON-C1 CBK HAMILTON MEDICAL AG 161001 07630002800747

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown