BEUDAMED
    FDA Adverse Event Death Summary report: N

    SERVO-I

    MDR report key: 6934205 · Received October 10, 2017

    Report

    Report Number
    6934205
    Event Type
    Death
    Date Received
    October 10, 2017
    Date of Event
    September 3, 2017
    Report Date
    September 22, 2017
    Manufacturer
    MAQUET MEDICAL SYSTEMS USA
    Product Code
    CBK
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    RT NOTED THAT THE VENT ALARMED "REGULATION PRESSURE REACHED." PEAK PRESSURES INCREASED WHILE TIDAL VOLUME DROPPED. RT BEGAN TROUBLESHOOTING AND DISASSEMBLED CIRCUIT, REMOVED FILTER, AND RE-ASSEMBLED THE CIRCUIT WITHOUT FILTER TO REMOVE ANY POSSIBLE AIRWAY OBSTRUCTION. ISSUE WAS NOT RESOLVED. REPLACEMENT OF VENTILATOR RESULTED IN RESTORATION OF NORMAL OPERATION. THE PATIENT EXPIRED 9 DAYS LATER. FROM RT PRESENT AT TIME OF ISSUE: "THE VENT WAS ALARMING "REGULATION PRESSURE LIMITED" BUT PRESSURE WAS ONLY 17 WHILE THE ALARM WAS SET AT 45, NO MINUTE VENTILATION, NO TIDAL VOLUMES, AND PEEP WAS READING 25 WHILE SET AT 12. THE VENT WAS MAKING A LOUD NOISE WITH EVERY BREATH IT WAS TRYING TO DELIVER. THE PATIENT WAS DESATTING DURING ALL THIS AND SO WAS TAKEN OFF AND BAGGED, WHILE NEW VENT WAS PUT INTO SERVICE. ALL ISSUES FIXED WITH NEW VENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    716579 SERVO-I VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET MEDICAL SYSTEMS USA SERVO-I

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Death NONE THAT WOULD CONTRIBUTE TO THE DEVICE FAILURE.