BEUDAMED
    FDA Adverse Event Death Summary report: N

    SERVO-I

    MDR report key: 4135173 · Received September 25, 2014

    Report

    Report Number
    8010042-2014-00437
    Event Type
    Death
    Date Received
    September 25, 2014
    Date of Event
    August 18, 2014
    Report Date
    August 26, 2014
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K123149
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION FROM HOSPITAL STATES THAT THE VENTILATOR WAS NOT SEQUESTERED AFTER THE INCIDENT SINCE THERE WAS NO CONCERN THAT THE VENTILATOR CONTRIBUTED TO THE PATIENT'S DEATH. THE VENTILATOR HAS NOT BEEN INVESTIGATED BY THE MANUFACTURER SINCE THERE WAS NO CONCERN ABOUT A VENTILATOR MALFUNCTION. NO PARTS WERE REPLACED AND THE VENTILATOR HAS BEEN USED CONTINUOUSLY AFTER THE INCIDENT. THE DEVICE LOG WERE DOWNLOADED BY THE HOSPITAL. EVALUATION OF THE DEVICE LOGS SHOWS THAT THE EVENT LOGS START ON (B)(6) 2014 IN ONGOING VENTILATION THAT CONTINUED UNTIL THE DATE AND TIME FOR THE EVENT, (B)(6) 2014 AT 10:40 WHEN THE VENTILATOR WAS SET TO STANDBY. THE LOGS SHOW THAT RELEVANT NAVA ALARMS WERE GENERATED UNTIL THE VENTILATOR WAS SET TO STANDBY. THE CONCLUSION IN THE MATTER IS THAT THE VENTILATOR WAS FUNCTIONING NORMALLY AND IT ALARMED FOR THE SITUATION. THERE WAS NO VENTILATOR MALFUNCTION AND THIS IS SUPPORTED BY ABSENCE OF TECHNICAL ALARMS AND THE HOSPITALS STATEMENT THAT THE VENTILATOR DID NOT MALFUNCTION IN ANY WAY. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REQUESTED A PRESENTATION DUE TO SOME CONCERNS ABOUT THE SAFETY OF USING NAVA ON NEONATES. ACCORDING TO THE HOSPITAL, A CHRONICALLY VENTILATED PATIENT WITH SEVERE BRONCHO PULMONARY DISEASE, THAT WAS USING NAVA HAD A CARDIAC ARREST AND SUBSEQUENTLY EXPIRED. ON (B)(6) 2014, THE PATIENT DEVELOPED A SPONTANEOUS PNEUMOTHORAX, REQUIRING CHEST TUBE PLACEMENT WITH COMPLETE EVACUATION OF THE PNEUMOTHORAX. THE CHEST TUBE FELL OUT EARLY MORNING OF (B)(6) 2014 AND A CHEST X-RAY REVEALED AT THE MOST A TINY PNEUMOTHORAX AND THEREFORE THE CHEST TUBE WAS NOT REPLACED. A FEW HOURS LATER THE PATIENT'S PNEUMOTHORAX ACCUMULATED AND DESPITE CHEST TUBE PLACEMENT AND EVACUATION OF THE FREE AIR, THE PATIENT EXPIRED AT 10:56 AFTER 32 WEEKS OF VENTILATION. NAVA (NEURALLY ADJUSTED VENTILATORY ASSIST) IS A VENTILATION MODE WHERE THE VENTILATOR DELIVERS ASSIST IN PROPORTION TO AND IN SYNCHRONY WITH THE PATIENT'S EDI SIGNAL (THE ELECTRICAL ACTIVITY OF THE DIAPHRAGM). AN EDI CATHETER WITH ELECTRODES IS USED TO MEASURE THE ELECTRICAL ACTIVITY OF THE DIAPHRAGM WHICH IS USED TO TRIGGER VENTILATOR BREATHS SYNCHRONOUS WITH THE PATIENT'S BREATHING EFFORTS. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596913 SERVO-I CBK CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1 221 DA Death