BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-T1

    MDR report key: 21135996 · Received January 13, 2025

    Report

    Report Number
    3001421318-2025-00113
    Event Type
    Malfunction
    Date Received
    January 13, 2025
    Date of Event
    December 18, 2024
    Report Date
    November 20, 2025
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002801850
    PMA / PMN Number
    K181216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG EVENT REFERENCE NUMBER: (B)(4). THE INTERNAL PRODUCT INVESTIGATION IS STILL ONGOING. AS SOON AS THE RESULTS ARE AVAILABLE, THE MANUFACTURER WILL SUBMIT AN UPDATE OF THIS REPORT UNSOLICITED.

    Additional Manufacturer Narrative · 0

    TECHNICAL EVENT:232056 (PLAUSIBILITY BETWEEN PAMBIENT AND PFILTER FAILED) AND SELF TEST FAILED AT START-UP DURING NON CLINICAL USE. NO PATIENT WAS INVOLVED. THE EVENT DID NOT CAUSE OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY TO A PATIENT. TO ADDRESS THE ISSUE, A CONTROL BOARD WAS SHIPPED TO THE CUSTOMER. NO FEEDBACK WAS RECEIVED CONFIRMING WHETHER THE REPLACEMENT RESOLVED THE ISSUE. ALTHOUGH THE OUTCOME COULD NOT BE VERIFIED, IT IS ASSUMED THAT THE ISSUE WAS RESOLVED BY REPLACING THE CONTROL BOARD, AS NO FURTHER ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 0

    THE EVENT DESCRIPTION ACCORDING TO THE CUSTOMER IS AS FOLLOWS: THE DEVICE FAILED SELF TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452485 HAMILTON-T1 HAMILTON-T1 CBK HAMILTON MEDICAL AG 161006 07630002801850

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown