BEUDAMED
    FDA Adverse Event Death Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 17562564 · Received August 17, 2023

    Report

    Report Number
    3001421318-2023-02907
    Event Type
    Death
    Date Received
    August 17, 2023
    Date of Event
    August 14, 2023
    Report Date
    August 17, 2023
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002800747
    PMA / PMN Number
    K181216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    505

    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: OUR EQUIPMENT DEPARTMENT RECEIVED A PHONE CALL FROM THE ICU MEDICAL STAFF INFORMING US THAT A VENTILATOR IN THE DEPARTMENT SUDDENLY WENT BLANK AND FAILED TO RESTART. IMMEDIATELY, OUR EQUIPMENT MAINTENANCE PERSONNEL WENT TO THE SITE TO INVESTIGATE AND HANDLE THE INCIDENT. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1707783 HAMILTON MEDICAL AG HAMILTON-C1 CBK HAMILTON MEDICAL AG HAMILTON-C1 07630002800747

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown