BEUDAMED
    FDA Adverse Event Death Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 17817540 · Received September 26, 2023

    Report

    Report Number
    3001421318-2023-11321
    Event Type
    Death
    Date Received
    September 26, 2023
    Date of Event
    August 31, 2022
    Report Date
    September 26, 2023
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    QA
    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: NO FURTHER INVESTIGATION OR CORRECTION WILL BE PERFORMED EXCEPT THOSE MENTIONED ABOVE. IN FUTURE HAMILTON MEDICAL AG WILL REPORT AN EVENT SIMILAR TO THIS ISSUE AS IT WILL BE DEEMED A REPORTABLE EVENT. THE ALLEGATION IN THIS COMPLAINT WAS CONFIRMED TO BE A COMPLAINT. WITH THIS INVESTIGATION IT HAS BEEN CONFIRMED THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS AT THE TIME OF THE EVENT WHILE THE VENTILATOR WAS USED. THE ROOT CAUSE WAS DETERMINED TO BE A DEFECTIVE SERVO MODULE (INSPIRATORY VALVE). IN CONSEQUENCE (CORRECTION) THE DEFECTIVE INSPIRATORY VALVE WAS REPLACED WITH AN MSP HAMILTON-G5 INSPIRATION VALVE (PART NUMBER 10082605, RGA 83146). THE PATIENT DIED. THE PATIENT DEATH WAS NOT CAUSED BY THE VENTILATOR, BUT THE PATIENT DIED DUE TO A HEART ATTACK. THERE WAS NO USER HARM.

    Description of Event or Problem · 0

    WE GOT A CASE OF HAMILTON S1 DEVICE SHUT DOWN DURING VENTILATION. UNFORTUNATELY THE PATIENT HAS PASSED AWAY RESULTING THE SHUTDOWN. A FULL INVESTIGATION IS REQUIRED TO WHY THE ERROR HAPPENED AND WHAT IS THE COUSES OF THE SHUTDOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1097414 HAMILTON MEDICAL AG HAMILTON-S1 CBK HAMILTON MEDICAL AG HAMILTON-S1

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death