BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 16689210 · Received April 6, 2023

    Report

    Report Number
    3001421318-2023-01283
    Event Type
    Malfunction
    Date Received
    April 6, 2023
    Date of Event
    March 28, 2023
    Report Date
    May 12, 2025
    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
    505

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG CASE NUMBER: CER (B)(4). ADDITIONAL INFORMATION ADDED IN FOLLOW-UP #1 CER 110168. FIELD B4, G6, H2, H3, H6 AND H11 UPDATED. DURING START UP THE OPTIONS DISAPPEARED IN CONFIGURATION MENU. NO PATIENT INVOLVED. CONSEQUENTLY, THE EVENT DID NOT CAUSE OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY. THE OPTIONS DISAPPEARED / OPTIONS NOT FOUND ISSUE MANIFESTS DURING DEVICE BOOT-UP, BEFORE THERAPY IS INITIATED OR A PATIENT IS CONNECTED. THEREFORE, IT IS IMMEDIATELY DETECTED, EVEN PRIOR TO ALL MANDATORTY TESTS THAT NEED TO BE EXECUTED BEFORE USING THE DEVICE ON A PATIENT. THE ISSUE CAN BE RESOLVED BY STANDARD USER OR SERVICE ACTIONS (E.G., REBOOTING, VERIFYING LICENSE KEYS, OR RELOADING CONFIG). CONSEQUENTLY, THIS MALFUNCTION IS NOT CLASSIFIED AS A CRITICAL FAILURE OR A REPORTABLE EVENT UNDER STANDARD MEDICAL DEVICE REGULATIONS. SINCE IT OCCURS RIGHT AT BOOT UP AND THE VENTILATOR UNDERGOES MANDATORY VALIDATION BEFORE EVERY USE, ANY DEVICE THAT DOES NOT START WILL SIMPLY BE IDENTIFIED AS NON-OPERATIONAL AND REPLACED OR SERVICED BEFORE IT CAN BE CONSIDERED FOR PATIENT CARE. 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

    IT WAS REPORTED TO HAMILTON MEDICAL AG: OPTIONS DISAPPEARED / OPTIONS NOT FOUND. NO PATIENT INVOLVED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO HAMILTON MEDICAL AG: OPTIONS DISAPPEARED / OPTIONS NOT FOUND. NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1852854 HAMILTON MEDICAL AG HAMILTON-C1 CBK HAMILTON MEDICAL AG 161001 07630002800747

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown