BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-C2

    MDR report key: 18397197 · Received December 27, 2023

    Report

    Report Number
    3001421318-2023-04329
    Event Type
    Malfunction
    Date Received
    December 27, 2023
    Date of Event
    November 10, 2023
    Report Date
    July 28, 2024
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    PMA / PMN Number
    K121225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG COMES TO THE CONCLUSION: INVESTIGATION ONGOING.

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG COMES TO THE CONCLUSION: ROOTCAUSE: DEFECT PRESSURE SENSOR ASSEMBLY AND FLOW SENSOR QVENT CORRECTION: REPLACED DEFECTIVE COMPONENTS. HAMILTON MEDICAL AG COMPLAINT NUMBER: (B)(4). FOLLOW-UP 2 - CORRECTED INFORMATION: **UDI RELATED DATA QUALITY UPDATES ONLY** FIELD D4 WERE UPDATED WITH FULL UDI INFORMATION AS REQUESTED.

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG COMES TO THE CONCLUSION: ROOTCAUSE: DEFECT PRESSURE SENSOR ASEMBLY AND FLOW SENSOR QVENT CORRECTION: REPLACED DEFECTIVE COMPONENTS.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: SUMMARY: LEAK TEST FAILED ( TIGHTNESS TEST FAILED).

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: SUMMARY: LEAK TEST FAILED ( TIGHTNESS TEST FAILED).

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: SUMMARY: LEAK TEST FAILED ( TIGHTNESS TEST FAILED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2308920 HAMILTON-C2 HAMILTON-C2 VENTILATOR CBK HAMILTON MEDICAL AG 160001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown