BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-T1

    MDR report key: 19331354 · Received May 16, 2024

    Report

    Report Number
    3001421318-2024-01164
    Event Type
    Malfunction
    Date Received
    May 16, 2024
    Date of Event
    April 29, 2024
    Report Date
    February 12, 2025
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002806091
    PMA / PMN Number
    K181216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG CASE NUMBER IS (B)(4). INVESTIGATION ONGOING. FOLLOW-UP 1 - CORRECTED INFORMATION: **UDI RELATED DATA QUALITY UPDATES ONLY** FIELD D4 WAS UPDATED WITH FULL UDI INFORMATION. UPDATED FIELDS: B4, D1, D4, G6, H2, H4, H11.

    Additional Manufacturer Narrative · 0

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

    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. UPDATED FIELDS. FOLLOW-UP 2 - ADDITIONAL INFORMATION: UPDATED FIELDS. INVESTIGATION RESULT: FINAL REPORTABILITY ASSESSMENT: ALTHOUGH THERE WAS NO PATIENT INVOLVEMENT AND, ACCORDING TO THE USER, THE DEVICE STARTED ALARMING WITHOUT USERS' INTERVENTION, THE OCCURRED TECHNICAL EVENTS AND FAULTS COULD POTENTIALLY LEAD TO NECESSARY INTERVENTION UNDER LESS FORTUNATE CIRCUMSTANCES. THEREFORE, THIS CASE REMAINS REPORTABLE. HAMILTON MEDICAL AG HAS NOT RECEIVED THE DEVICE FOR INVESTIGATION. HOWEVER, THE LOGFILES OF THE DEVICE WERE RECEIVED FOR ANALYSIS. THE FOLLOWING CAN BE SEEN: SEVERAL TECHNICAL EVENTS (246005, 246009, 232029) AND TECHNICAL FAULTS (485001, 446028, 431001, 446029) WERE LOGGED ON THE REPORTED DATE OF 29.04.2024, AFTER THE VENTILATION SOFTWARE WAS STARTED 15:39:30. FURTHERMORE TECHNICAL FAULT 444044 WAS LOGGED INDICATING VOLTAGES OUT OF TOLERANCE. ACCORDING TO THE ERROR LOG, THE REQUIRED 24 VOLT WAS TOO LOW (5.014 VOLT) AND THEREFORE TF 431001 (BLOWER FAULT) WAS ALERTED. THE SERVICE TECHNICIAN ON SITE INSPECTED THE DEVICE AND EXCHANGED THE CONTROL BOARD. AFTER THE REPLACEMENT OF THE CONTROL BOARD NO FURTHER ISSUES REGARDING THE DEVICE WERE REPORTED. THE ROOT CAUSE DETERMINED IS A DEFECTIVE CONTROL BOARD.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: THIS EVENT WAS REPORTED TO HAMILTON MEDICAL AG AS, VENTILATOR DEVICE WAS IN STANDBY AND WENT INTO ALARM WITHOUT ANY USER'S INTERVENTION. THE VENTILATOR DEVICE ALARMED WITH THE TECHNICAL EVENT 246005, THE TECHNICAL EVENT 232029, THE TECHNICAL ERROR 485001, THE TECHNICAL ERROR 431001 AND THE TECHNICAL ERROR 446029 AND SWITCHED TO AMBIENT MODE. THIS OCCURRENCE WAS NOTICED WHILE THE AMBULANCE WAS DRIVING. THERE WAS NO PATIENT CONNECTED TO THE VENTILATOR DEVICE. THE DEVICE LOG FILES (SERVICE LOG, ERROR LOG, EVENT LOG) WERE PROVIDED TO HAMILTON MEDICAL AG. THERE IS NO NEED FOR ANY MEDICAL INTERVENTION REPORTED. NEITHER DELAY IN TREATMENT NOR HARM TO THE PATIENT, USER OR THIRD PARTY HAS BEEN REPORTED. THE INVESTIGATION IS STILL ONGOING.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: - THIS EVENT WAS REPORTED TO HAMILTON MEDICAL AG AS, VENTILATOR DEVICE WAS IN STANDBY AND WENT INTO ALARM WITHOUT ANY USER'S INTERVENTION. THE VENTILATOR DEVICE ALARMED WITH THE TECHNICAL EVENT 246005, THE TECHNICAL EVENT 232029, THE TECHNICAL ERROR 485001, THE TECHNICAL ERROR 431001 AND THE TECHNICAL ERROR 446029 AND SWITCHED TO AMBIENT MODE. - THIS OCCURRENCE WAS NOTICED WHILE THE AMBULANCE WAS DRIVING. THERE WAS NO PATIENT CONNECTED TO THE VENTILATOR DEVICE. - THE DEVICE LOG FILES (SERVICE LOG, ERROR LOG, EVENT LOG) WERE PROVIDED TO HAMILTON MEDICAL AG. - THERE IS NO NEED FOR ANY MEDICAL INTERVENTION REPORTED. - NEITHER DELAY IN TREATMENT NOR HARM TO THE PATIENT, USER OR THIRD PARTY HAS BEEN REPORTED. THE INVESTIGATION IS STILL ONGOING.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: - THIS EVENT WAS REPORTED TO HAMILTON MEDICAL AG AS, VENTILATOR DEVICE WAS IN STANDBY AND WENT INTO ALARM WITHOUT ANY USER'S INTERVENTION. THE VENTILATOR DEVICE ALARMED WITH THE TECHNICAL EVENT 246005, THE TECHNICAL EVENT 232029, THE TECHNICAL ERROR 485001, THE TECHNICAL ERROR 431001 AND THE TECHNICAL ERROR 446029 AND SWITCHED TO AMBIENT MODE. - THIS OCCURRENCE WAS NOTICED WHILE THE AMBULANCE WAS DRIVING. THERE WAS NO PATIENT CONNECTED TO THE VENTILATOR DEVICE. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633726 HAMILTON-T1 HAMILTON-T1 CBK HAMILTON MEDICAL AG 161009 07630002806091

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown