BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-C1

    MDR report key: 19653487 · Received July 2, 2024

    Report

    Report Number
    3001421318-2024-01578
    Event Type
    Malfunction
    Date Received
    July 2, 2024
    Date of Event
    June 25, 2024
    Report Date
    October 25, 2024
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002800747
    PMA / PMN Number
    K181216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG CASE NUMBER IS: (B)(4). FOLLOW-UP 1 - CORRECTED INFORMATION: **UDI RELATED DATA QUALITY UPDATES ONLY** FIELD D4 WAS UPDATED WITH FULL UDI INFORMATION. UPDATED FIELDS: B4, D1, D4, G6, H2, H4, H11.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: SELF TEST FAILED ALARM AND TECHNICAL EVENTS SUCH AS 233001,233003 ,233004. ALL THE TECHNICAL EVENTS ARE RELATED TO AUTO ZERO . WE TRIED TO DO ALL CALIBRATION BUT IT WAS NOT FUNCTIONING. DONE TESTS SUCH AS AUTO ZERO AND BINARY VALVE ETC THOSE ARE NOT OK. WE ARE SUSPECTING PRESSURE SENSOR ASSEMBLY. BUT IN THIS VENTILATOR WE RECENTLY HAVE BEEN ALREADY REPLACED PRESSURE SENSOR ASSEMBLY ON 01-MARCH -2024. NO PATIENT INVOLVEMENT

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: SELF TEST FAILED ALARM AND TECHNICAL EVENTS SUCH AS 233001,233003 ,233004. ALL THE TECHNICAL EVENTS ARE RELATED TO AUTO ZERO. WE TRIED TO DO ALL CALIBRATION BUT IT WAS NOT FUNCTIONING. DONE TESTS SUCH AS AUTO ZERO AND BINARY VALVE ETC THOSE ARE NOT OK. WE ARE SUSPECTING PRESSURE SENSOR ASSEMBLY. BUT IN THIS VENTILATOR, WE RECENTLY HAVE BEEN ALREADY REPLACED PRESSURE SENSOR ASSEMBLY ON (B)(6) -2024. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570905 HAMILTON-C1 HAMILTON-C1 CBK HAMILTON MEDICAL AG 161001 07630002800747

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown