BEUDAMED
    FDA Adverse Event Death Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 15433022 · Received September 15, 2022

    Report

    Report Number
    3001421318-2022-00013
    Event Type
    Death
    Date Received
    September 15, 2022
    Date of Event
    August 22, 2022
    Report Date
    September 15, 2022
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002800013
    PMA / PMN Number
    K193228
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG HAS NOT RECEIVED ANY INFORMATION CONCERNING THE CASE, OTHER THEN THE DEVICE INFORMATION AND THERE WAS NO CAUSALITY BETWEEN THE DEATH OF THE PATIENT AND THE VENTILATOR. SERVICE ENGINEER DID RUN THE VENTILATOR THROUGH COMPLETE TESTING, CALIBRATION, FUNCTIONAL ETC. NO PROBLEMS WERE FOUND. RT MANAGER CONFIRMED THAT THIS WAS NOT A VENTILATOR RELATED OCCURENCE. NO FURTHER INFORMATION ABOUT THE DETAILS CONCERNING THE DEATH OF THE PATIENT WERE RECEIVED. THIS REPORT IS GENERATED DUE TO THE DEATH OF THE PATIENT EVEN THOUGH THE DEVICE HAD NO INVOLVEMENT IN THE PATIENTS DEATH ACCORDING TO THE HOSPITAL. HAMILTON MEDICAL AG REFERENCE NR: (B)(4). HAMILTON MEDICAL INC. SUBMITTED THE REPORT REFERENCE NR: 0002937708-2022-00008 AS AN IMPORTER.

    Description of Event or Problem · 0

    HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: " I WAS CALLED BY THE BIOMED, (B)(6), AT (B)(6) TODAY ABOUT A G5 THAT, PER THE BIOMED: "EITHER THE VENT KICKED OFF OR THE RT KICKED IT OFF". THE PATIENT DID EXPIRE WHILE ON THE VENT. THIS WAS ALL THE INFO I WAS ABLE TO GET FROM THE BIOMED. I THEN CONTACTED THE SALES REP TO CONTACT THE RT DIRECTOR FOR A BETTER DESCRIPTION. THE STAFF INFORMED HIM THE PATIENT CODED, HAD A DNR, AND THIS WAS NOT A VENT ISSUE, BUT THE BIOMED STAFF HAVE THE VENT QUARANTINED, AND WOULD LIKE TO HAVE THE VENT CHECKED OUT BEFORE PUT BACK IN SERVICE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1875991 HAMILTON MEDICAL AG HAMILTON-G5 CBK HAMILTON MEDICAL AG HAMILTON-G5 07630002800013

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death