BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 17141041 · Received June 16, 2023

    Report

    Report Number
    3001421318-2023-02377
    Event Type
    Malfunction
    Date Received
    June 16, 2023
    Date of Event
    June 1, 2023
    Report Date
    June 16, 2023
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002800372
    PMA / PMN Number
    K201306
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AGS CONCLUSION: ROOTCAUSE: DEFECTIVE PRESSURE SENSOR ASSEMBLY. CORRECTION: REPLACEMEN OF THE DEFECTIVE COMPONENT.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: DETAILED COMPLAINT AND FAILURE DESCRIPTION: OPEN BOX FAILED. INVOICE NO:200225883.TF:231022. DEFECTIVE C1/T1 PRESSURE SENSOR ASSEMBLY. REPLACE C1/T1 PRESSURE SENSOR ASSEMBLY, IT'S OK! SUMMARY: TECHNICAL EVENT: 231022 (PEXPVALVE SENSOR DEFECT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2198804 HAMILTON MEDICAL AG HAMILTON-C1 VENTILATOR CBK HAMILTON MEDICAL AG 160001 07630002800372

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown