BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 17823060 · Received September 27, 2023

    Report

    Report Number
    3001421318-2023-03376
    Event Type
    Malfunction
    Date Received
    September 27, 2023
    Date of Event
    August 24, 2023
    Report Date
    November 10, 2025
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002800747
    PMA / PMN Number
    K181216
    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 CASE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: TECHNICAL EVENT: 246005,232035,232008, 233006, 233003, 233004, 233001 ON START UP. TECHNICAL EVENT:246005 TALLS_ALARMMONITORDEFECT, TECHNICAL EVENT:232035 TABM_PFILTERSENSORDEFECT, TECHNICAL EVENT:232008 TABM_PAMBIENTSENSORDEFECT, TECHNICAL EVENT:233006 TABPG_NEBULIZERVALVEERROR, TECHNICAL EVENT:233003 TABPG_AUTOZEROPAWFAIL, TECHNICAL EVENT:233004 TABPG_AUTOZEROQAWFAIL, TECHNICAL EVENT:233001 TABPG_AUTOZEROPVENTMONITORFAIL. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    972970 HAMILTON MEDICAL AG HAMILTON-C1 CBK HAMILTON MEDICAL AG HAMILTON-C1 07630002800747

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown