BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 1429106 · Received July 30, 2009

    Report

    Report Number
    8010042-2009-00141
    Event Type
    Malfunction
    Date Received
    July 30, 2009
    Date of Event
    July 5, 2009
    Report Date
    July 6, 2009
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K062793
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE VENTILATOR HAS A VENTILATION MODE NAVA (NEURALLY ADJUSTED VENTILATORY ASSIST). A SINGLE USE NASO-GASTRIC CATHETER WITH ELECTRODES (EDI CATHETER) IS USED TO MEASURE THE ELECTRICAL ACTIVITY OF THE DIAPHRAGM WHICH IS USED TO TRIGGER VENTILATOR BREATHS SYNCHRONOUS WITH THE PT'S BREATHING EFFORTS. IT WAS REPORTED THAT WHEN THE EDI-CATHETER WAS REMOVED AFTER THREE DAYS OF USE, IT HAD VISIBLE LONG CRACKS. THE EDI-CATHETER WAS POSITIONED NEXT TO A FRESH DUODENUM CATHETER. IT WAS REPOSITIONED AFTER ABOUT TWO HOURS. AFTER TWO DAYS OF USE THERE WERE INCREASED EDI SYNC ALARMS AND SEVERAL ATTEMPTS WERE MADE TO RESTART NAVA. ON THE THIRD DAY THE EDI CATHETER WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERVO-I CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1