BEUDAMED
    FDA Adverse Event Death Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 17696575 · Received September 7, 2023

    Report

    Report Number
    3001421318-2023-03110
    Event Type
    Death
    Date Received
    September 7, 2023
    Date of Event
    August 7, 2023
    Report Date
    March 10, 2025
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    PMA / PMN Number
    K181216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    505

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG CASE NUMBER IS: (B)(4). CORRECTED DATA IN FOLLOW UP REPORT NR. 1: H1 (DEATH WAS MARKED BEFORE WHICH WAS A MISTAKE).

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG CASE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG CASE NUMBER IS: (B)(4). CORRECTED DATA IN FOLLOW UP REPORT NR. 1: H1 (DEATH WAS MARKED BEFORE WHICH WAS A MISTAKE). A DETAILED INVESTIGATION WAS PERFORMED BY AN EXPERT FROM THE TECHNICAL SERVICE: THE ALLEGATION IN THIS COMPLAINT WAS CONFIRMED TO BE A COMPLAINT. WITH THIS INVESTIGATION IT HAS BEEN CONFIRMED THAT THE COAXIAL BREATHING CIRCUIT SET FAILED TO MEET ITS SPECIFICATIONS DUE TO A LEAKAGE IN THE OUTER TUBE. THE ROOT CAUSE WAS DETERMINED TO BE DURING HANDLING IN MANUFACTURING. IN CONSEQUENCE THE BREATHING CIRCUIT WAS REPLACED. THERE WAS NO PATIENT OR USER HARM, AS THIS ISSUE HAS BEEN DETECTED DURING THE PREOPERATIONAL TIGHTNESS CHECK ON THE VENTILATOR.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: "CES ENGINEER ATTENDED FAULTY WITH HAMILTON T1 VENTILATOR IN ED. THE VENTILATOR WAS FAILING THE DEVICE TEST WITH A LEAK. THE LEAK WAS LOCATED ON THE PATIENT CIRCUIT. THE TUBING IS MALFORMED, WITH HEAT MARKS PRODUCING HOLES IN 3 X PLACES ON THE CORRUGATED TUBING." NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: "CES ENGINEER ATTENDED FAULTY WITH HAMILTON T1 VENTILATOR IN ED. THE VENTILATOR WAS FAILING THE DEVICE TEST WITH A LEAK. THE LEAK WAS LOCATED ON THE PATIENT CIRCUIT. THE TUBING IS MALFORMED, WITH HEAT MARKS PRODUCING HOLES IN 3 X PLACES ON THE CORRUGATED TUBING." NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: "CES ENGINEER ATTENDED FAULTY WITH HAMILTON T1 VENTILATOR IN ED. THE VENTILATOR WAS FAILING THE DEVICE TEST WITH A LEAK. THE LEAK WAS LOCATED ON THE PATIENT CIRCUIT. THE TUBING IS MALFORMED, WITH HEAT MARKS PRODUCING HOLES IN 3 X PLACES ON THE CORRUGATED TUBING." NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1166864 HAMILTON MEDICAL AG BREATHING CIRCUIT SET CBK HAMILTON MEDICAL AG BREATHING CIRCUIT SET, COAXIAL 181356

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown