BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-T1

    MDR report key: 22562936 · Received July 22, 2025

    Report

    Report Number
    3001421318-2025-00702
    Event Type
    Malfunction
    Date Received
    July 22, 2025
    Date of Event
    June 16, 2025
    Report Date
    July 22, 2025
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    PMA / PMN Number
    K181216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG REF NR: (B)(4). NO UDI INFORMATION AVAILABLE AS DEVICE WAS MANUFACTURED PRIOR TO REQUIREMENT. INVESTIGATION: LOCAL SERVICE ENGINEER IDENTIFIED CONTROL BOARD (MSP161502) AS DEFECTIVE COMPONENT. REPLACEMENT OF THIS PART RESOLVED THE ISSUE. DEVICE PASSED ALL TESTS AND RETURNED IN USE.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: "DEVICE CAME IN WITH NUMEROUS TFS 246005, 232029, 485001, 431001, 446029, 246009, 443001. REPLACING CONTROL BOARD CLEARED ALL FAULTS. DEVICE PASSED ALL TESTS AND RETURNED TO SERVICE." NO PATIENT INVOLVEMENT. ALTHOUGH, NO PATIENT INVOLVEMENT WAS REPORTED, HAMILTON MEDICAL'S INITIAL ASSESSMENT OF THE CASE SHOWED AN "AMBIENT" IN THE LOG FILES. PATIENT INVOLVEMENT HAS NOT BEEN CONFIRMED BY THE CUSTOMER. BUT THE AMBIENT IS VISIBLE IN THE LOG FILE AND SEEN AS CRITICAL IF IT WERE TO RECUR. DUE TO THESE UNKNOWN CIRCUMSTANCES AND AN AMBIENT MODE LISTED IN THE LOG FILES, THIS CASE IS ASSESSED AS REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    778666 HAMILTON-T1 HAMILTON-T1 CBK HAMILTON MEDICAL AG 161001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown