BEUDAMED
    FDA Adverse Event Summary report: N

    SERVO-I

    MDR report key: 1152443 · Received August 15, 2008

    Report

    Report Number
    1152443
    Date Received
    August 15, 2008
    Date of Event
    August 11, 2008
    Report Date
    August 15, 2008
    Manufacturer
    MAQUET, INC.
    Product Code
    CBK
    Report Source
    User Facility report
    Reporter Location
    CT, US

    Narratives

    Description of Event or Problem · 1

    RESPIRATORY THERAPY SET UP THE NICU VENTILATOR. DURING THE 3 TO 7 PM SHIFT AN ALARM WENT OFF; WHILE TROUBLE SHOOTING THE REASON FOR THE ALARM, IT WAS THOUGHT THAT THE GRAY TEMPERATURE PROBE WIRE HAD A KINK IN IT SO IT WAS EXCHANGED. SEVERAL HOURS LATER, THE VENTILATOR ALARMED. A SECOND RESPIRATORY THERAPIST EXCHANGED THE ENTIRE HEATER UNIT. SEVERAL HOURS LATER, THE VENTILATOR ALARMED AGAIN. A THIRD RESPIRATORY THERAPIST NOTED THAT THE INSPIRATORY TUBE WAS CONNECTED TO THE EXPIRATORY PORT, AND THE EXPIRATORY TUBE WAS CONNECTED TO THE INSPIRATORY PORT. BECAUSE THE TUBES WERE CONNECTED IMPROPERLY, THE AIR BEING INSPIRED WAS NOT BEING HEATED (WRONG TUBING WAS CONNECTED) AND THE TEMPERATURE OF THE AIR WAS DECREASING, CAUSING THE ALARM. THE TUBING IS ABLE TO BE CONNECTED TO EITHER PORT. THERE IS NO COLOR CODE ON THE VENT TO PREVENT MISCONNECTION; THERE IS ALSO NO KEY INDEX ON THE VENTILATOR OR TUBING TO PREVENT MISCONNECTION. THE VENTILATOR WOULD DELIVER THE CORRECT THERAPY AS SET ON THE VENTILATOR; THE NEONATE JUST WOULD NOT RECEIVE THE HUMIDIFIED AIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERVO-I VENTILATOR CBK MAQUET, INC. SERVO-I *

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DAY OTHER| OTHER