BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-MR1

    MDR report key: 18595815 · Received January 29, 2024

    Report

    Report Number
    3001421318-2024-00224
    Event Type
    Malfunction
    Date Received
    January 29, 2024
    Date of Event
    January 5, 2024
    Report Date
    November 11, 2024
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002813556
    PMA / PMN Number
    K153046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG CASE NUMBER IS (B)(4). FOLLOW-UP 1 - CORRECTED INFORMATION: UDI RELATED DATA QUALITY UPDATES ONLY. FIELD D4 WAS UPDATED WITH FULL UDI INFORMATION.

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG CASE NUMBER IS CER (B)(4). INVESTIGATION ONGOING.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: THIS EVENT WAS REPORTED TO HAMILTON WHILE THE CUSTOMER EXPERIENCED DIFFICULTIES WITH ADJUSTING THE VENTILATOR DEVICE IN A WAY (IN PCV+ MODUS) TO ENSURE THAT THE VENTILATION IS ADEQUATE. FOR SOME REASONS (EITHER DUE TO THE PATIENT'S HEALTH CONDITION OR DUE TO TRANSPORT WITHIN THE HOSPITAL TO THE MRI ROOM) THE CUSTOMER REPORTED THAT THEY SWITCHED BACK AND FORWARD BETWEEN THIS HAMILTON-MR1 (IN PCV+ MODE) AND A ICU VENTILATOR. BOTH VENTILATOR DEVICES HAD THE SAME SETTINGS. THE NEONATAL PATIENT WAS SEDATED. BLOOD PRESSURE AND HEARTBEAT OF THE NEONATAL PATIENT INCREASED RAPIDLY. THE END-TIDAL CO2 MEASURED VALUE WAS 9. FINALLY, BY USING THE HAMILTON-MR1 IN SIMV MODE, THE PATIENT'S CONDITION STABILIZED AND REMAINED STABLE THROUGHOUT THE MRI SESSION. IT WAS NOT REPORTED WHETHER ALARMS WERE TRIGGERED. THE DEVICE LOG FILES WERE PROVIDED TO HAMILTON. THERE IS PATIENT INVOLVEMENT REPORTED. NEITHER DELAY IN TREATMENT NOR HARM TO THE PATIENT, USER OR THIRD PARTY HAS BEEN REPORTED. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: THIS EVENT WAS REPORTED TO HAMILTON WHILE THE CUSTOMER EXPERIENCED DIFFICULTIES WITH ADJUSTING THE VENTILATOR DEVICE IN A WAY (IN PCV+ MODUS) TO ENSURE THAT THE VENTILATION IS ADEQUATE. FOR SOME REASONS (EITHER DUE TO THE PATIENT'S HEALTH CONDITION OR DUE TO TRANSPORT WITHIN THE HOSPITAL TO THE MRI ROOM) THE CUSTOMER REPORTED THAT THEY SWITCHED BACK AND FORWARD BETWEEN THIS HAMILTON-MR1 (IN PCV+ MODE) AND A ICU VENTILATOR. BOTH VENTILATOR DEVICES HAD THE SAME SETTINGS. THE NEONATAL PATIENT WAS SEDATED. BLOOD PRESSURE AND HEARTBEAT OF THE NEONATAL PATIENT INCREASED RAPIDLY. THE END-TIDAL CO2 MEASURED VALUE WAS 9. FINALLY, BY USING THE HAMILTON-MR1 IN SIMV MODE, THE PATIENT'S CONDITION STABILIZED AND REMAINED STABLE THROUGHOUT THE MRI SESSION. IT WAS NOT REPORTED WHETHER ALARMS WERE TRIGGERED. THE DEVICE LOG FILES WERE PROVIDED TO HAMILTON. THERE IS PATIENT INVOLVEMENT REPORTED. NEITHER DELAY IN TREATMENT NOR HARM TO THE PATIENT, USER OR THIRD PARTY HAS BEEN REPORTED. THE INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    796832 HAMILTON-MR1 HAMILTON-MR1 CBK HAMILTON MEDICAL AG 1610100 07630002813556

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown