BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-C6

    MDR report key: 18665783 · Received February 8, 2024

    Report

    Report Number
    3001421318-2024-00308
    Event Type
    Malfunction
    Date Received
    February 8, 2024
    Date of Event
    January 28, 2024
    Report Date
    September 30, 2024
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002808590
    PMA / PMN Number
    K201658
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG COMES TO THE CONCLUSION: ROOT CAUSE: DEFECTIVE COMMUNICATION BOARD (PN 160184 OR 160185). CORRECTION: REPLACE COMMUNICATION BOARD (PN 160184 OR 160185).

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG COMES TO THE CONCLUSION: ROOT CAUSE: DEFECTIVE COMMUNICATION BOARD (PN 160184 OR 160185) CORRECTION: REPLACE COMMUNICATION BOARD (PN 160184 OR 160185) HAMILTON MEDICAL AG COMPLAINT NUMBER: CER (B)(4) FOLLOW-UP 1 - CORRECTED INFORMATION: UDI RELATED DATA QUALITY UPDATES ONLY FIELD D4 WAS UPDATED WITH FULL UDI INFORMATION. UPDATED FIELDS.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: SUMMARY: DEVICE ALARMED WITH "AEROGEN NEBULIZER DISCONNECTED" DURING VENTILATION.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: SUMMARY: DEVICE ALARMED WITH "AEROGEN NEBULIZER DISCONNECTED" DURING VENTILATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2305989 HAMILTON-C6 HAMILTON-C6 VENTILATOR CBK HAMILTON MEDICAL AG 160021 07630002808590

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown