BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-C6

    MDR report key: 17993995 · Received October 24, 2023

    Report

    Report Number
    3001421318-2023-03609
    Event Type
    Malfunction
    Date Received
    October 24, 2023
    Date of Event
    September 30, 2023
    Report Date
    August 13, 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: ROOTCAUSE: INTERACTION PANEL FRONT MSP160840 DEFECTIVE. CORRECTION: INTERACTION PANEL FRONT MSP160840 REPLACEMENT.

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG COMES TO THE CONCLUSION: ROOTCAUSE: INTERACTION PANEL FRONT MSP160840 DEFECTIVE. CORRECTION: INTERACTION PANEL FRONT MSP160840 REPLACEMENT. CORRECTED DATE IN G2: (B)(6) 2024.

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG COMES TO THE CONCLUSION: ROOTCAUSE: INTERACTION PANEL FRONT MSP160840 DEFECTIVE. CORRECTION: INTERACTION PANEL FRONT MSP160840 REPLACEMENT. CORRECTED DATE IN G2: 01.31.2024. 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: SEE (B)(4).

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: SUMMARY: DEVICE OPENS UP WINDOWS ITSELF AND CHANGE SETTINGS.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: SUMMARY: DEVICE OPENS UP WINDOWS ITSELF AND CHANGE SETTINGS.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: SUMMARY: DEVICE OPENS UP WINDOWS ITSELF AND CHANGE SETTINGS.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: SUMMARY: DEVICE OPENS UP WINDOWS ITSELF AND CHANGE SETTINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    813365 HAMILTON-C6 HAMILTON-C6 VENTILATOR CBK HAMILTON MEDICAL AG 160021 07630002808590

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown