BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 16634100 · Received March 29, 2023

    Report

    Report Number
    3001421318-2023-01014
    Event Type
    Malfunction
    Date Received
    March 29, 2023
    Date of Event
    March 9, 2023
    Report Date
    March 29, 2023
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002808590
    PMA / PMN Number
    K201306
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCLUSION OF CER 110110: THE INVESTIGATION RESULT IS THE FOLLOWING: FAILURE MODE DESCRIPTION: TF 232035, TF232029. FAILURE EFFECT: ALARM VISUALLY AND AUDIBLY. ROOT CAUSE: DEFECTIVE BLOWER. CORRECTION: BLOWER REPLACED, NO TE VISIBLE . THE BLOWER MODULE HAS BEEN IDENTIFIED TO BE THE FAULTY COMPONENT.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: TE 232035 DURING START-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    824361 HAMILTON MEDICAL AG HAMILTON-C3 VENTILATOR CBK HAMILTON MEDICAL AG 160021 07630002808590

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown