BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERVO-U

    MDR report key: 8491245 · Received April 8, 2019

    Report

    Report Number
    8010042-2019-00245
    Event Type
    Injury
    Date Received
    April 8, 2019
    Date of Event
    March 18, 2019
    Report Date
    July 5, 2019
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K108898
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    GETINGE USA SALES, LLC (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF MAQUET CRITICAL CARE AB (MANUFACTURER). REF. EXEMPTION #: E2018003. GETINGE USA SALES, LLC 45 BARBOUR POND DRIVE WAYNE, NJ 07470. CONTACT PERON: (B)(4).

    Additional Manufacturer Narrative · 0

    NO PARTS WERE REPLACED THEREFORE THE INVESTIGATION CONSISTS OF AN EVALUATION OF THE LOGS AND INFORMATION FROM THE HOSPITAL. THE EVALUATION OF THE LOGS SHOWS THAT THEY DO NOT CONTAIN ANYTHING THAT SUGGESTS THAT THERE WAS A VENTILATOR MALFUNCTION AT THE TIME. THE VENTILATOR FUNCTIONED AS SET IN THE HIGH FLOW THERAPY MODE OF VENTILATION. IN THE HIGH FLOW THERAPY MODE OF VENTILATION THE VENTILATOR DELIVERS A SET FLOW OF HEATED AND HUMIDIFIED GAS WITH A SET CONCENTRATION OF OXYGEN TO THE PATIENT WHO MUST BE BREATHING SPONTANEOUSLY. THE CONNECTION TO THE PATIENT IS BY THE HIGH FLOW NASAL CANNULA OR TRACHEOSTOMY INTERFACE. THE VENTILATION MODE HAS LIMITED ALARMS WHERE MOST OF THE OTHER ALARMS ARE NOT AVAILABLE. THE USER IS ALWAYS ADVISED TO USE EXTERNAL MONITORING. THE MODE OF VENTILATION BY ITSELF IS A DISCONNECTION PROVIDING A CONTINUOUS FLOW WITH NO EXPIRATORY FLOW BEING RETURNED TO THE VENTILATOR WHICH IMPLIES THAT THERE CANNOT BE A DISCONNECT ALARM. THE CONCLUSION IS THAT THERE WAS NO VENTILATOR MALFUNCTION AT THE TIME. THERE WAS NO DISCONNECTION ALARM TO EXPECT BECAUSE IT IS NOT AVAILABLE. THE CAUSE WAS THE CIRCUIT WITH THE NASAL CANNULA THAT WAS BEING USED TO DELIVER THE HIGH FLOW. THE CONNECTOR WAS TIGHT AT START OF CONNECTION BUT GOT VERY LOOSE DURING USE AND GOT DISCONNECTED WHEN THE CIRCUIT WAS HEATED AND HUMIDIFIED. EXTERNAL MONITORING WAS IN USE AS RECOMMENDED AND IT ALARMED BUT THE ALARMS WERE NOT ATTENDED TO.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD BECOME DISCONNECTED FROM THE CIRCUIT. THE PATIENT WAS USING THE F & P HIGH FLOW SET, WITH THE WHITE BING REMOVED AND A GREEN CONNECTOR USED TO CONNECT THE TWO. THE PATIENT WAS FULLY MONITORED WITH ALL THE REQUIRED MONITORING DEVICES. THE PATIENT CENTRAL MONITORING ALARMS WERE GOING OFF HOWEVER ALL OF THE STAFF WERE BUSY DEALING WITH OTHER PATIENTS AND WERE UNABLE TO ATTEND TO THE PATIENT. WHEN THE STAFF DID ATTEND TO THE ALARMS THE PATIENT WAS FOUND IN A PULSE LESS STATE AND A CRASH CALL WAS RAISED AND THE NECESSARY PROTOCOLS WERE FOLLOWED. THE PATIENT¿S FINAL OUTCOME IS UNKNOWN. MANUFACTURER REFERENCE#: (B)(4).

    Description of Event or Problem · 0

    MANUFACTURER REFERENCE#: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287223 SERVO-U VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening