BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 17780206 · Received September 20, 2023

    Report

    Report Number
    3001421318-2023-03297
    Event Type
    Malfunction
    Date Received
    September 20, 2023
    Date of Event
    September 4, 2023
    Report Date
    September 20, 2023
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002801881
    PMA / PMN Number
    K201306
    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: DEFECTIVE INSPIRATORY VALVE. CORRECTION: REPLACED INSPIRATORY VALVE.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: DETAILED COMPLAINT AND FAILURE DESCRIPTION: ALARM'231005' HAPPENED WHEN PATIENT USING THE VENTILATION,ATER,OUR CUSTOMER REPLACED THE VENTILATOR FOR THE PATIENTIT.IT DID NOT BRING ANY ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84457 HAMILTON MEDICAL AG HAMILTON-C3 VENTILATOR CBK HAMILTON MEDICAL AG 07630002801881

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown