BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 3915693 · Received June 12, 2014

    Report

    Report Number
    8010042-2014-00258
    Event Type
    Malfunction
    Date Received
    June 12, 2014
    Date of Event
    May 16, 2014
    Report Date
    October 6, 2020
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K062793
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REMOVED EDI CATHETER HAS BEEN REQUESTED BACK FOR INVESTIGATION. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PT TREATMENT WHILE USING THE NAVA (NEURALLY ADJUSTED VENTILATORY ASSIST) VENTILATION, PROBLEMS WERE OBSERVED WITH THE EDI (ELECTRICAL ACTIVITY OF THE DIAPHRAGM) SIGNAL. THE EDI CATHETER THAT IS USED FOR PICKING UP THE EDI SIGNAL WAS REMOVED FROM THE PT AFTER 2 DAYS OF USE. IT WAS THEN OBSERVED THAT ITS ELECTRODES WERE PROTRUDING FROM THE WALL OF THE EDI CATHETER. A NEW EDI CATHETER WAS INSERTED AND NAVA VENTILATION CONTINUED WITHOUT PROBLEM. THERE WAS NO PT HARM. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346890 SERVO-I VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1