BEUDAMED
    FDA Adverse Event Death Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 17562163 · Received August 17, 2023

    Report

    Report Number
    3001421318-2023-02902
    Event Type
    Death
    Date Received
    August 17, 2023
    Date of Event
    August 11, 2023
    Report Date
    May 16, 2024
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002800747
    PMA / PMN Number
    K181216
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    505

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG CASE NUMBER IS: (B)(4). FOLLOW-UP NR. 1: INVESTIGATION: NO DEVICE PROBLEM WAS FOUND DURING INVESTIGATION OF THE REPORTED PROBLEM AND TESTING THE DEVICE. THE LOG FILES DO NOT SHOW ANY MALFUNCTION OR DEFECT OF THE VENTILATOR. THE BIOMED WAS NOT ABLE TO REPRODUCE ANY FAILURES DURING THE TESTING PERIOD. ACCORDING TO THE BIOMED MANAGER, THE ISSUE WAS ULTIMATELY DESCRIBED AS BEING "AN ISSUE WITH RESPIRATORY", AND HE DID NOT BELIEVE THE PROBLEM ORIGINATED FROM THE VENTILATOR. WHAT PRECISELY THE RESPIRATORY ISSUE WAS, REMAINS UNKNOWN. THE PATIENT'S SPO2 WAS NOT BEING MONITORED AND DESATURATION MAY HAVE OCCURRED DURING THE EVENT. THE ROOT CAUSE OF THE EVENT COULD HOWEVER NOT BE DETERMINED. ON THE 10TH OF APRIL 2024 THE BIOMED INFORMED US THAT FOR HIM THE CAUSE OF THE PATIENT'S DEATH REMAINS UNKNOWN. NO CORRECTION WAS DONE AS NO PROBLEM WAS FOUND WITH THE DEVICE. THE FIELD TECHNICIAN TESTED THE VENTILATOR. ALL CALIBRATIONS, TEST SOFTWARE, PREOPERATIONAL CHECKS, AND FUNCTIONAL TESTING WERE COMPLETED WITH NO FAILURES OR FAULTS FOUND. THE VENTILATOR RAN OVERNIGHT ON HI FLOW AT VARIOUS OXYGEN SETTINGS WITH NO FAILURES. AFTER COMPLETELY AND SUCCESSFULLY TESTING THE DEVICE, THE VENTILATOR WAS RETURNED FOR PATIENT USE.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: PATIENT PASSED AWAY DURING VENTILATION. VERY LITTLE DETAILS, THE HOSPITAL IS NOT SHARING INFO WITH THE BIOMED. WE DO NOT HAVE ACCESS TO THE VENT SO NO LOG FILES ARE AVAILABLE.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: PATIENT PASSED AWAY DURING VENTILATION. VERY LITTLE DETAILS, THE HOSPITAL IS NOT SHARING INFO WITH THE BIOMED. WE DO NOT HAVE ACCESS TO THE VENT SO NO LOG FILES ARE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1793226 HAMILTON MEDICAL AG HAMILTON-C1 CBK HAMILTON MEDICAL AG HAMILTON-C1 07630002800747

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death