BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-T1

    MDR report key: 21557059 · Received March 10, 2025

    Report

    Report Number
    3001421318-2025-00390
    Event Type
    Malfunction
    Date Received
    March 10, 2025
    Date of Event
    February 7, 2025
    Report Date
    February 13, 2026
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    PMA / PMN Number
    K181216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG COMPLAINT NUMBER:(B)(4). CREATION OF UDI WAS NOT A REQUIREMENT AT THE TIME OF MANUFACTURING OF THIS DEVICE AND HAD NOT YET BEEN IMPLEMENTED IN PRODUCTION. INVESTIGATION ONGOING.

    Additional Manufacturer Narrative · 0

    INVESTIGATION OUTCOME: IT WAS REPORTED THAT DEVICE FAILED 'DIST. AUTOZERO VALVE' UNDER 'PNEUMATICS 1' IN SERVICE SOFTWARE. IT IS UNKNOWN WHETHER IT FAILED DURING OPERATION OR AUTOZERO MODE. NO PATIENT INVOLVEMENT. NO DEVICE LOGS WERE PROVIDED WITH THIS COMPLAINT. THE ISSUE OCCURED DURING SERVICE SOFTWARE WHILE UNDERGOING THE NORMAL TESTS. PRESSURE SENSOR ASSEMBLY WAS IDENTIFIED AS DEFECTIVE ASSEMBLY BY LOCAL BIOMED. HAMILTON MEDICAL INC. SHIPPED A PRESSURE SENSOR ASSEMBLY TO CUSTOMER. IT IS UNKNOWN IF THE REPLACEMENT OF THIS PART RESOLVED THE ISSUE AS NO FEEDBACK WAS RECEIVED. THIS CASE IS CONSIDERED AS CLOSE.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: QUOTATION FROM THE REPORTER: "DURING PM, ON BINARY VALVE FOR THE PNEUMATICS 1 OF THE COMP TEST, RECEIVED A "NOT OK" ON THE DIST. AUTOZERO VALVE." "RECEIVED CONTINUOUS FAILURE AFTER RUNNING TEST MULTIPLE TIMES." NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2104476 HAMILTON-T1 HAMILTON-T1 CBK HAMILTON MEDICAL AG 161006

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown