BEUDAMED
    FDA Adverse Event Death Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 15433771 · Received September 15, 2022

    Report

    Report Number
    3001421318-2022-00008
    Event Type
    Death
    Date Received
    September 15, 2022
    Date of Event
    August 28, 2022
    Report Date
    September 8, 2022
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002800747
    PMA / PMN Number
    K181216
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG HAS NOT RECEIVED ANY INFORMATION CONCERNING THE CASE, OTHER THEN THE DEVICE INFORMATION AND THAT A USER ERROR CAUSED THE DEATH OF THE PATIENT. NO FURTHER INFORMATION ABOUT THE USER ERROR AND/OR 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 WORKED AS INTENDED AND HAS HAD NO INVOLVEMENT IN THE PATIENTS DEATH ACCORDING TO THE HOSPITAL. HAMILTON MEDICAL AG REFERENCE NR: (B)(4).

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: BIOMED INFORMED ME THAT USER ERROR RESULTED IN PATIENT HARM/DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1527755 HAMILTON MEDICAL AG HAMILTON-C1 CBK HAMILTON MEDICAL AG HAMILTON-C1 07630002800747

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death