BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-T1

    MDR report key: 19039531 · Received April 4, 2024

    Report

    Report Number
    3001421318-2024-00794
    Event Type
    Malfunction
    Date Received
    April 4, 2024
    Date of Event
    February 1, 2024
    Report Date
    November 6, 2024
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002806091
    PMA / PMN Number
    K181216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG COMPLAINT NUMBER: (B)(4). FOLLOW-UP 1 - CORRECTED INFORMATION: UDI RELATED DATA QUALITY UPDATES ONLY FIELD D4 WAS UPDATED WITH FULL UDI INFORMATION. UPDATED FIELDS.

    Description of Event or Problem · 0

    THE FOLLOWING HAS BEEN REPORTED TO HAMILTON MEDICAL AG ON 16 FEBRUARY 2024 FROM A CUSTOMER IN INDIA IT WAS REPORTED THAT ON (B)(6) 2024, DURING PREVENTIVE MAINTENANCE, HAMILTON T1 (SN (B)(6)) FOUND O2 FLOW TEST GOT FAILED AND TECHNICAL EVENT 231008 & 231007. AS IMMEDIATE ACTION PERFORMED: REPLACED O2 INLET FILTER, PROBLEM NOT RECTIFIED. CLEANED AND FIXED O2 MIXER ASSEMBLY, PROBLEM NOT RECTIFIED. REPLACED NEW O2 MIXER ASSEMBLY, PROBLEM RECTIFIED. MACHINE WORKING FINE. ALL TEST AND CALIBRATION DONE. ACCORDING TO PRELIMINARY ANALYSIS PERFORMED, POTENTIAL ROOT CAUSE ANALYSIS ASSOCIATED TO THE REPORTED ISSUE COULD BE RELATED TO: DEFECTIVE O2 PROPORTIONAL VALVE, MIXER ASSEMBLY OR LEAK IN LPO INLET ACCORDINGLY, THE FOLLOWING CORRECTION SHALL BE CONSIDERED: CHECK THE LPO INLET FOR LEAKS AS THIS COULD LEAD TO 231008 EVEN THOUGH THE O2 VALVE IS WORKING PROPERLY. IF HPO IS USED THEN MAKE SURE NO LPO CONNECTOR IS CONNECTED TO THE LPO INLET. AND CHECK THE O2 MIXER FOR PROPER FUNCTION WITH SERVICE SOFTWARE,PNEUMATICS 2,O2 INPUT (PAGE 2112) AND SYSTEM TEST, O2 MIXER (PAGE 2203) AND INSTALL LATEST SOFTWARE VERSION AND REPLACE THE O2 MIXER ASSEMBLY. NO PATIENT IS INVOLVED AS PER AVAILABLE INFORMATION, THERE IS NO INDICATION THAT THE COMPLAINT LEAD TO DEATH, INJURY OR SERIOUS DETERIORATION OF THE HEALTH OF THE PATIENT, USER OR THIRD-PARTY.

    Description of Event or Problem · 0

    THE FOLLOWING HAS BEEN REPORTED TO HAMILTON MEDICAL AG ON (B)(6) 2024 FROM A CUSTOMER IN INDIA. IT WAS REPORTED THAT ON FERUARY 01ST 2024, DURING PREVENTIVE MAINTENANCE, HAMILTON T1 (SN (B)(6) FOUND O2 FLOW TEST GOT FAILED AND TECHNICAL EVENT 231008 & 231007. AS IMMEDIATE ACITON PERFORMED: REPLACED O2 INLET FILTER, PROBLEM NOT RECTIFIED. CLEANED AND FIXED O2 MIXER ASSEMBLY, PROBLEM NOT RECTIFIED. REPLACED NEW O2 MIXER ASSEMBLY, PROBLEM RECTIFIED. MACHINE WORKING FINE. ALL TEST AND CALIBRATION DONE. ACCORDING TO PRELIMINARY ANALYSIS PERFORMED, POTENTIAL ROOT CAUSE ANALYSIS ASSOCIATED TO THE REPORTED ISSUE COULD BE RELATED TO: DEFECTIVE O2 PROPORTIONAL VALVE, MIXER ASSEMBLY OR LEAK IN LPO INLET. ACCORDINGLY, THE FOLLOWING CORRECTION SHALL BE CONSIDERED: CHECK THE LPO INLET FOR LEAKS AS THIS COULD LEAD TO 231008 EVEN THOUGH THE O2 VALVE IS WORKING PROPERLY. IF HPO IS USED THEN MAKE SURE NO LPO CONNECTOR IS CONNECTED TO THE LPO INLET. AND CHECK THE O2 MIXER FOR PROPER FUNCTION WITH SERVICE SOFTWARE, PNEUMATICS 2, O2 INPUT (PAGE 2112) AND SYSTEM TEST, O2 MIXER (PAGE 2203) AND INSTALL LATEST SOFTWARE VERSION AND REPLACE THE O2 MIXER ASSEMBLY. NO PATIENT IS INVOLVED AS PER AVAILABLE INFORMATION, THERE IS NO INDICATION THAT THE COMPLAINT LEAD TO DEATH, INJURY OR SERIOUS DETERIORATION OF THE HEALTH OF THE PATIENT, USER OR THIRD-PARTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2340087 HAMILTON-T1 HAMILTON-T1 CBK HAMILTON MEDICAL AG 161009 07630002806091

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other