BEUDAMED
    FDA Adverse Event Death Summary report: N

    SERVO-I

    MDR report key: 1672264 · Received April 30, 2010

    Report

    Report Number
    8010042-2010-00078
    Event Type
    Death
    Date Received
    April 30, 2010
    Date of Event
    March 30, 2010
    Report Date
    April 1, 2010
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K062793
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 10 DAYS AFTER VENTILATION OF A PT CONNECTED TO A VENTILATOR, THE PT'S CONDITION WORSENED. VENTILATION SETTINGS WERE CHANGED E.G. INCREASE OF THE RESPIRATORY RATE. HIGH PEEP (POSITIVE END EXPIRATORY PRESSURE) ALARMS WERE GENERATED. ONE DAY LATER, THE PT WAS DISCONNECTED FROM THE VENTILATOR AND CONNECTED TO HFO (HIGH FREQUENCY OSCILLATORY) VENTILATION FOR TWO HOURS BUT NO IMPROVEMENT WAS NOTED. THE VENTILATOR WAS RECONNECTED TO THE PT. THE PT DIED 7 HOURS LATER. THE DIAGNOSES WERE CARCINOMA AND PNEUMOMEDIASTINUM. (B) (4). (B) (4).

    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 Death