BEUDAMED
    FDA Adverse Event Death Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 17823018 · Received September 27, 2023

    Report

    Report Number
    3001421318-2023-16182
    Event Type
    Death
    Date Received
    September 27, 2023
    Date of Event
    February 19, 2022
    Report Date
    September 27, 2023
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002813549
    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: NO FURTHER INVESTIGATION OR CORRECTION WILL BE PERFORMED EXCEPT THOSE MENTIONED ABOVE. THE ALLEGATION IN THIS COMPLAINT WAS CONFIRMED TO BE A COMPLAINT. WITH THIS INVESTIGATION IT HAS NOT BEEN CONFIRMED THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS AT THE TIME OF THE EVENT WHILE THE VENTILATOR WAS USED WITH A PATIENT. IT IS REPORTED THAT THE PATIENT DIED. A CLEAR ROOT CAUSE WAS NOT DETERMINED BUT THE MOST PROBABLE MAY BE A USAGE ISSUE. THE COMPLAINT IS REPORTABLE.

    Description of Event or Problem · 0

    THE COMPLAINT WAS RECEIVED FOR AN EVENT DATE ON (B)(6) 2022, STATING "T1 HAMILTON VENTILATOR WAS INVOLVED IN AN INCIDENT THAT RESULTED IN THE DEATH OF A PATIENT. AROUND 8:00 AM ON (B)(6) 2022 THE STAFF WAS NOTIFIED TO MOVE THE PATIENT FROM THE ICU TO THE CATH LAB FOR A PROCEDURE. THE PATIENT WAS ON A HAMILTON G5 VENTILATOR IN THE ICU THEN THE STAFF WANTED TO TRANSFER THE PATIENT FROM THE G5 TO THE T1 VENTILATOR TO TRANSPORT THE PATIENT TO THE CATH LAB. DURING THAT TIME OF TRANSFERRING THE PATIENT TO THE T1 VENTILATOR IS WHEN THE STAFF NOTICED THAT THE PATIENT VITALS WERE GOING DOWN. THE STAFF REMOVED THE PATIENT FROM THE T1 VENTILATOR THEN GAVE THE PATIENT BAGS OF BREATH ATTEMPTING REVIVE THE PATIENT BACK TO LIFE." THE IMPORTER OF THE DEVICE (HAMILTON MEDICAL INC.) REPORTED THIS EVENT TO FDA (0002937708-2022-00004).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1019030 HAMILTON MEDICAL AG HAMILTON-T1 CBK HAMILTON MEDICAL AG HAMILTON-T1 07630002813549

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death