BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-T1

    MDR report key: 19077489 · Received April 10, 2024

    Report

    Report Number
    3001421318-2024-00879
    Event Type
    Malfunction
    Date Received
    April 10, 2024
    Date of Event
    March 9, 2023
    Report Date
    November 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
    CA
    Reporter Occupation
    505

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG CASE NUMBER IS: (B)(4). 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.   UPDATED FIELDS: B4, D1, D3, D4, G6, H2, H4, H11.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: I'M SENDING THIS EMAIL BECAUSE WE HAVE TWO T1S THAT THE USERS SAID HAD AN ISSUE WHEN IN THE HIGH FLOW O2 MODE. THEY SAID "OVER THE WEEKEND THE TEAM SET UP HIGH FLOW AND AT THE START OF THIS MODE THE HAMILTON WAS NOT DELIVERING ANY FLOW. IT RESOLVED FOR BOTH BY TURNING THE VENT OFF AND THEN BACK ON. BOTH TEAMS WENT THROUGH TROUBLE SHOOTING AND THERE WAS NOT ANYTHING IDENTIFIED TO IMPACT THIS". I CHECKED BUT WASN'T ABLE TO REPRODUCE THE REPORTED ISSUE WITH EITHER VENT. BOTH VENTS WORKED FINE IN THE HIGH FLOW O2 MODE RIGHT AWAY FOR ME, BUT WOULD LIKE BOMIMED/HAMILTON TO HAVE A LOOK AT THE ATTACHED EVENT AND INSTRUMENT LOGS FROM THESE TWO VENTS SN (B)(6) TO SEE IF THERE IS ANYTHING IN THEM THAT MAY EXPLAIN WHAT MAY HAVE CAUSED THE ISSUE NOTED. I CAN SEE IN THE EVENT LOGS (WHEN DISPLAYED ON THE T1 SCREEN) THAT THEY DID TURN ON THE VENTS, SET THEM TO HIGH FLOW O2 MODE AND LET IT RUN FOR JUST FEW MINUTES BEFORE TURNING THEM OFF AND RESTARTING THEM AGAIN IN THE HIGH FLOW O2 MODE AGAIN BEFORE IT SEEMED LIKE MAYBE IT WAS WORKING FOR THEM. START DATE/TIME WAS ON MAR 10TH AROUND 4PM-5PM FOR YOUR REFERENCE. PATIENT DESATURATION BUT RECOVERED, NO HEALTH CONSEQUENCES OR IMPACT.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: I'M SENDING THIS EMAIL BECAUSE WE HAVE TWO T1S THAT THE USERS SAID HAD AN ISSUE WHEN IN THE HIGH FLOW O2 MODE. THEY SAID "OVER THE WEEKEND THE TEAM SET UP HIGH FLOW AND AT THE START OF THIS MODE THE HAMILTON WAS NOT DELIVERING ANY FLOW. IT RESOLVED FOR BOTH BY TURNING THE VENT OFF AND THEN BACK ON. BOTH TEAMS WENT THROUGH TROUBLE SHOOTING AND THERE WAS NOT ANYTHING IDENTIFIED TO IMPACT THIS". I CHECKED BUT WASN'T ABLE TO REPRODUCE THE REPORTED ISSUE WITH EITHER VENT. BOTH VENTS WORKED FINE IN THE HIGH FLOW O2 MODE RIGHT AWAY FOR ME, BUT WOULD LIKE BOMIMED/HAMILTON TO HAVE A LOOK AT THE ATTACHED EVENT AND INSTRUMENT LOGS FROM THESE TWO VENTS (SN: (B)(6)) TO SEE IF THERE IS ANYTHING IN THEM THAT MAY EXPLAIN WHAT MAY HAVE CAUSED THE ISSUE NOTED. I CAN SEE IN THE EVENT LOGS (WHEN DISPLAYED ON THE T1 SCREEN) THAT THEY DID TURN ON THE VENTS, SET THEM TO HIGH FLOW O2 MODE AND LET IT RUN FOR JUST FEW MINUTES BEFORE TURNING THEM OFF AND RESTARTING THEM AGAIN IN THE HIGH FLOW O2 MODE AGAIN BEFORE IT SEEMED LIKE MAYBE IT WAS WORKING FOR THEM. START DATE/TIME WAS ON MAR 10TH AROUND 4PM-5PM FOR YOUR REFERENCE. PATIENT DESATURATION BUT RECOVERED, NO HEALTH CONSEQUENCES OR IMPACT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412435 HAMILTON-T1 HAMILTON-T1 CBK HAMILTON MEDICAL AG 161006 07630002801850

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown