BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-C6

    MDR report key: 18928559 · Received March 19, 2024

    Report

    Report Number
    3001421318-2024-00654
    Event Type
    Malfunction
    Date Received
    March 19, 2024
    Date of Event
    February 24, 2024
    Report Date
    October 1, 2024
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002808590
    PMA / PMN Number
    K201658
    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 COMES TO THE CONCLUSION: INVESTIGATION ONGOING. 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: B4, D1, D4, G6, H2, H4, H5, H11.

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG COMES TO THE CONCLUSION: INVESTIGATION ONGOING.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: SUMMARY:AFTER START UP DEVICE IS GIVING SELF TEST FAILED WITH TECHNICAL FAULT 431002 AND WHEN I MADE FLOW SENSOR CALIBRATION AND TIGHTNESS TEST THE DEVICE IS GIVING TECHNICAL EVENTS 231032 AND 231009.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: SUMMARY:AFTER START UP DEVICE IS GIVING SELF TEST FAILED WITH TECHNICAL FAULT 431002 AND WHEN I MADE FLOW SENSOR CALIBRATION AND TIGHTNESS TEST THE DEVICE IS GIVING TECHNICAL EVENTS 231032 AND 231009.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2276314 HAMILTON-C6 HAMILTON-C6 VENTILATOR CBK HAMILTON MEDICAL AG 160021 07630002808590

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown