BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 16929586 · Received May 15, 2023

    Report

    Report Number
    3001421318-2023-01759
    Event Type
    Malfunction
    Date Received
    May 15, 2023
    Date of Event
    May 11, 2023
    Report Date
    May 15, 2023
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002801881
    PMA / PMN Number
    K201306
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    505

    Narratives

    Additional Manufacturer Narrative · 0

    HAMITLON MEDICAL AGS CONCLUSION: INVESTIGATION ONGOING.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: SUMMARY: TF 243004 (BUZZER DEFECT AT STARTUP) OR BUZZER DEFECTIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1475196 HAMILTON MEDICAL AG HAMILTON-C3 VENTILATOR CBK HAMILTON MEDICAL AG 160005 07630002801881

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown