BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 17149703 · Received June 19, 2023

    Report

    Report Number
    3001421318-2023-02403
    Event Type
    Malfunction
    Date Received
    June 19, 2023
    Date of Event
    June 11, 2023
    Report Date
    November 30, 2023
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002801881
    PMA / PMN Number
    K201658
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG COMES TO THE CONCLUSION: IN SUMMARY, THE LOGFILE ANALYSIS CONFIRMED THE OCCURRENCE, TIMING AND THE REPORTED TECHNICAL FAILURES TECHNICAL FAULT (TF) 233003 AND TF 233004 OF THE EVENT. TE 233003 & 233004 HAPPEND DURING HIFLOWO2 THERAPY. THE COMPLETE DEVICE HAD BEEN TESTED BY SERVICE SCHWEIZ HAMILTON MEDICAL AND NO FAILURE HAD BEEN FOUND. THE ROOT CAUSE COULD NOT BE IDENFTIED. THEREFORE, NO CORRECTIONS WERE PERFORMED.

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG COMES TO THE CONCLUSION: INVESTIGATION ONGOING.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: TF 233003 UND TF 233004 OCCURED DURING VENTILATION (HIFLOWO2) . SUMMARY: DEVICE ALARMS WITH LOW PRIO: TECHNICAL EVENT: 233003 - AUTOZERO PAW FAIL TECHNICAL EVENT: 233004 - AUTOZERO QAW FAIL VENTILATION CONTINUES.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: TF 233003 UND TF 233004 OCCURED DURING VENTILATION (HIFLOWO2) . SUMMARY: DEVICE ALARMS WITH LOW PRIO: TECHNICAL EVENT: 233003 - AUTOZERO PAW FAIL, TECHNICAL EVENT: 233004 - AUTOZERO QAW FAIL. => VENTILATION CONTINUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2066449 HAMILTON MEDICAL AG HAMILTON-C3 VENTILATOR CBK HAMILTON MEDICAL AG 160005 07630002801881

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown