BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-T1

    MDR report key: 21271046 · Received January 30, 2025

    Report

    Report Number
    3001421318-2025-00189
    Event Type
    Malfunction
    Date Received
    January 30, 2025
    Date of Event
    January 15, 2025
    Report Date
    January 13, 2026
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002806091
    PMA / PMN Number
    K181216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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.

    Additional Manufacturer Narrative · 0

    INVESTIGATION OUTCOME: IT WAS REPORTED ON THE PROVIDED COMPLAINT FORM "RELEASE VALVE DEFECTIVE, ERROR CODE. PHYSICAL DAMAGES AND PM PARTS REQUIRED. BATTERIES NEED TO BE REPLACED DUE TO AGE" AND "SHOWN IN CALIBRATIONS / VISUALLY". DEVICE LOGS WERE NOT PROVIDED WITH THIS COMPLAINT. ATTEMPTS WERE MADE TO REQUEST THE LOGS AND ADDITIONAL INFORMATION. HAMILTON MEDICAL INC. SENT THE CHECK VALVE ASSEMBLY WITH OBSTRUCTION VALVE (MSP161192) TO BE REPLACED BY THE CUSTOMER. THERE WAS NO RESPONSE AFTER THREE REQUESTS FOR ADDITIONAL INFORMATION IF REPLACING IT RESOLVED THE ISSUE. THE COMPLAINT MAY BE REEVALUATED IF ADDITIONAL INFORMATION IS RECEIVED. COMPLAINT IS CONSIDERED CLOSED.

    Description of Event or Problem · 0

    THE FOLLOWING WERE REPORTED TO HAMILTON MEDICAL AG: THE RELEASE VALVE WAS DEFECT, ERROR CODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681107 HAMILTON-T1 HAMILTON-T1 CBK HAMILTON MEDICAL AG 161009 07630002806091

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown