BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 12704301 · Received October 27, 2021

    Report

    Report Number
    8010042-2021-02586
    Event Type
    Malfunction
    Date Received
    October 27, 2021
    Date of Event
    September 27, 2021
    Report Date
    October 27, 2021
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K123149
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION WAS DONE BY ANALYSIS OF DATA THE DAY AFTER THE INSERTION OF THE EDI CATHETER. THE ANALYSIS DETERMINED THAT THE EDI CATHETER MEASURED THE EDI-SIGNAL IN A FAULTY POSITION THAT WAS NOT IN PHASE WITH THE PRESSURE. THE EDI CATHETER WAS POSITIONED TOO FAR UP. THE POSITIONING OF THE EDI CATHETER WAS DONE USING THE NEUROBOX POSITIONING WINDOW. THE NEUROBOX HAS A SLIGHTLY SIMPLIFIED GRAPHICAL SUPPORT IN THE POSITIONING WINDOW. THE MALPOSITIONING WAS NOT NOTICED. THE CLINICAL TEAM BELIEVED THAT THE PATIENT DID NOT BREATH CLINICALLY DUE TO VIRUS INDUCED HYPOVENTILATION. THE DATA ANALYSIS ALSO SHOWED THAT THE PATIENT WAS NOT BREATHING FOR LONG PERIODS MAKING IT DIFFICULT TO POSITION THE CATHETER. THE PATIENT WAS IN BACKUP VENTILATION FOR MOST OF THE PERIOD. THE CONCLUSION IN THE MATTER IS THAT THE REASON FOR THE MALPOSITIONING OF THE CATHETER WAS MOST LIKELY A COMBINATION OF MISINTERPRETATION OF THE POSITIONING WINDOW IN THE NEUROBOX AND THE BELIEF THAT THE LOW EDI WAS CAUSED BY THE PATIENT¿S CONDITION. H3 OTHER TEXT : DATA ANALYSIS.

    Description of Event or Problem · 0

    MANUFACTURER'S REF #: (B)(4).

    Description of Event or Problem · 1

    WHILE ANALYZING VENTIALTORY DATA FROM A VENTILATOR USED IN A STUDY USING EDI SIGNALS, IT WAS NOTICED THE EDI CATHETER WAS MALPOSITIONED. II WAS FAR UP AND IT WAS DETECTING OTHER ADDITIONAL SIGNALS OTHER THAN THE INTENDED SIGNAL FROM THE DIAPHRAGM. THIS CONDITION WAS NOT NOTICED BY THE USER. THERE WAS NO PATIENT HARM. MANUFACTURER¿S REF. #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1603698 SERVO-I VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB SERVO-I

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown