BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-C1

    MDR report key: 20222702 · Received September 16, 2024

    Report

    Report Number
    3001421318-2024-02228
    Event Type
    Malfunction
    Date Received
    September 16, 2024
    Date of Event
    August 19, 2024
    Report Date
    September 16, 2024
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002800747
    PMA / PMN Number
    K181216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    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: SELF TEST FAILED, WRONG EXPIRATORY VALVE. TECHNICAL EVENT: 232008, 232029, 232035, 232008, 233006, 233003, 233004, 233001. TECHNICAL FAULT: 431015, 444004, 431001, 446028. FAILURE OCCUR DURING CHECKING BEFORE PATIENT CONNECTION. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1107272 HAMILTON-C1 HAMILTON-C1 CBK HAMILTON MEDICAL AG 161001 07630002800747

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown