BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-T1

    MDR report key: 21906973 · Received April 25, 2025

    Report

    Report Number
    3001421318-2025-00555
    Event Type
    Malfunction
    Date Received
    April 25, 2025
    Date of Event
    March 26, 2025
    Report Date
    February 18, 2026
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002801850
    PMA / PMN Number
    K181216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG COMPLAINT NUMBER: (B)(4). INITIAL REPORT.

    Additional Manufacturer Narrative · 0

    INVESTIGATION OUTCOME: COMPLAINT DESCRIPTION: DAMAGE FROM FAULTY UPS. CONFIRMED THAT THE UNIT WAS NOT CHARGING IN THE WORKSHOP AND THAT THE VOLTAGE TEST POINT FOR POWER WAS 0 WHEN POWER WAS PLUGGED IN. CONFIRMED THAT THE UNIT WAS NOT CHARGING IN THE WORKSHOP AND THAT THE VOLTAGE TEST POINT FOR POWER WAS 0 WHEN POWER WAS PLUGGED IN CAPACITOR ON POWER SUPPLY BOARD HAS BEEN BLOWN. THE PROBLEM WAS SOLVED BY REPLACING THE POWER SUPPLY. THIS CASE IS CONSIDERED AS CLOSED.

    Description of Event or Problem · 0

    HAMILTON MEDICAL AG RECEIVED THE FOLLOWING INCIDENT DESCRIPTION: "DAMAGE FROM FAULTY UNINTERRUPTIBLE POWER SUPPLY (UPS). CONFIRMED THAT THE UNIT WAS NOT CHARGING IN THE WORKSHOP AND THAT THE VOLTAGE TEST POINT FOR POWER WAS ZERO WHEN POWER WAS PLUGGED IN. CAPACITOR ON POWER SUPPLY BOARD HAS BEEN BLOWN". THERE IS NO PATIENT INVOLVEMENT. BASED ON THE ALLEGED INFORMATION REFERRING TO SOME BURNING SMELL FROM A CAPACITOR IN THE POWER SUPPLY, THIS EVENT IS ASSESSED AS REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    481195 HAMILTON-T1 HAMILTON-T1 CBK HAMILTON MEDICAL AG 161006 07630002801850

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown