BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-C1

    MDR report key: 20986303 · Received December 20, 2024

    Report

    Report Number
    3001421318-2024-02971
    Event Type
    Malfunction
    Date Received
    December 20, 2024
    Date of Event
    September 30, 2024
    Report Date
    December 20, 2024
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    PMA / PMN Number
    K181216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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 AFTER VENTILATOR STARTUP, ALARM CODE: 233004 (AUTOZERO ERROR QAW/PAW) DEFECTIVE PRESSURE SENSOR BOARD, REPLACED AND THE UNIT WAS REPAIRED AND HANDED OVER TO THE USER. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2061694 HAMILTON-C1 HAMILTON-C1 CBK HAMILTON MEDICAL AG 161001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown