BEUDAMED
    FDA Adverse Event Death Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 17817480 · Received September 26, 2023

    Report

    Report Number
    3001421318-2023-11411
    Event Type
    Death
    Date Received
    September 26, 2023
    Date of Event
    August 28, 2022
    Report Date
    September 26, 2023
    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
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT HAS BEEN REOPENED AND REVIEWED ACCORDING TO FDA FORM 483 INSPECTIONAL OBSERVATION EMS #2, EOBS2 FROM THE FDA INSPECTION CONDUCTED BETWEEN JULY 17 TO JULY 21, 2022 AT THE EMS AND BONADUZ SITES.  A DETAILED INVESTIGATION WAS PERFORMED BY AN EXPERT FROM THE TECHNICAL SERVICE: THERE IS NO MALFUNCTION ON THE DEVICE ITSELF. WITH THIS INVESTIGATION IT HAS BEEN CONFIRMED THAT THE DEVICE DID NOT FAIL TO MEET ITS SPECIFICATIONS AT THE TIME OF THE EVENT WHILE THE VENTILATOR WAS USED WITH A PATIENT. DUE TO THE USER ERROR, THE PATIENT DIED. THE COMPLAINT IS DEEMED REPORTABLE.

    Description of Event or Problem · 0

    BIOMED OF RENTAL FACILITY INFORMED ME THAT RT USER ERROR RESULTED IN PATIENT HARM/DEATH. UNIT WAS INVOLVED IN A PATIENT INCIDENT. REFER TO (B)(4). THE HOSPITAL WHO RENTED THE HAMILTON C1 "DID THEIR INTERNAL INVESTIGATION, AND IT WAS DETERMINED THAT THE VENTILATOR WAS NOT THE CAUSE OF DEATH, BUT IT WAS IN FACT USER ERROR". THE RENTAL FACILITY, US MED EQUIP, WHO OWNS THE UNIT, WANTS HMI TO PERFORM CALIBRATION/TEST ON THE UNIT TO MAKE SURE IT'S WORKING PROPERLY, AS A PRECAUTION. PERFORMED TSW AND FUNCTION TESTS; ALL PASSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    985169 HAMILTON MEDICAL AG HAMILTON-C1 CBK HAMILTON MEDICAL AG HAMILTON-C1 07630002800747

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death