BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 17141095 · Received June 16, 2023

    Report

    Report Number
    3001421318-2023-02378
    Event Type
    Malfunction
    Date Received
    June 16, 2023
    Date of Event
    June 5, 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

    HAMITLON MEDICAL AGS CONCLUSION: ROOTCAUSE: DEFECTIVE TURBINE. 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: THE REPORT FROM HOSPITAL SAY: ON THE MORNING OF JUNE 5, 2023, AT 9:45 AM, THE ICU DOCTOR WAS PREPARING TO USE THE VENTILATOR. HOWEVER, DURING THE POWER ON SELF TEST, THE SELF TEST FAILED AND AN ERROR MESSAGE "TECHNICAL EVENT: 232035" WAS REPORTED. THE VENTILATOR WAS IMMEDIATELY SENT TO THE EQUIPMENT DEPARTMENT FOR REPAIR AND PROCESSING. HOSPITAL ANALYSIS: 1. CIRCUIT BOARD FAILURE 2. TURBINE FAILURE. SUMMARY:TECHNICAL EVENT:232035 DURING START-UP (PFILTER SELFTEST FAILED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2135607 HAMILTON MEDICAL AG HAMILTON-C1 VENTILATOR CBK HAMILTON MEDICAL AG 160001 07630002800372

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown