BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-T1

    MDR report key: 18254741 · Received December 4, 2023

    Report

    Report Number
    3001421318-2023-04066
    Event Type
    Malfunction
    Date Received
    December 4, 2023
    Date of Event
    September 21, 2023
    Report Date
    August 5, 2024
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002801850
    PMA / PMN Number
    K181216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    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). INVESTIGATION ONGOING. HAMILTON MEDICAL AG COMPLAINT NUMBER: (B)(4). FOLLOW-UP 1 - CORRECTED INFORMATION: **UDI RELATED DATA QUALITY UPDATES ONLY** FIELD D4 WAS UPDATED WITH FULL UDI INFORMATION AS REQUESTED. UPDATED FIELDS: B4, D1, D4, G3, G6, H2, H4.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: THIS EVENT WAS REPORTED TO HAMILTON AS VENTILATOR DEVICE REPEATEDLY ALARMED FOR VARIOUS MEDIUM AND HIGH PRIORITY PATIENT ALARMS. VARIOUS ALARMS WERE OBSERVABLE BOTH VISUALLY AND THROUGH HEARING. THE LOG FILES SHOW PA141003(VTLOW), PA141005(LOW MINUTE VOLUME), PA 141017(DISCONNECTION ON PATIENT SIDE), PA 141014 (, TURNFLOWSENSOR), PA 141002 (VTHIGH) AND PA 141051 (PEEPHIGH). ALSO THE "FLOW SENSOR CALIBRATION" FAILED MULTIPLE TIMES. LATER BY RUNNING THE SERVICE SOFTWARE THE VENTILATOR DEVICE FAILED FOR THE "BLOWER FLOW TEST" ON HIGH FLOW VALUES. THERE IS NO PATIENT INVOLVEMENT REPORTED.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 AS VENTILATOR DEVICE REPEATEDLY ALARMED FOR VARIOUS MEDIUM AND HIGH PRIORITY PATIENT ALARMS. - VARIOUS ALARMS WERE OBSERVABLE BOTH VISUALLY AND THROUGH HEARING. THE LOG FILES SHOW PA141003(VTLOW), PA141005(LOW MINUTE VOLUME), PA 141017(DISCONNECTION ON PATIENT SIDE), PA 141014 (, TURNFLOWSENSOR), PA 141002 (VTHIGH) AND PA 141051 (PEEPHIGH). ALSO, THE "FLOW SENSOR CALIBRATION" FAILED MULTIPLE TIMES. LATER BY RUNNING THE SERVICE SOFTWARE THE VENTILATOR DEVICE FAILED FOR THE "BLOWER FLOW TEST" ON HIGH FLOW VALUES. - THERE IS NO PATIENT INVOLVEMENT REPORTED. - 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1539659 HAMILTON-T1 HAMILTON-T1 CBK HAMILTON MEDICAL AG 161006 07630002801850

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown