BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERVO-N

    MDR report key: 8217259 · Received January 4, 2019

    Report

    Report Number
    8010042-2019-00007
    Event Type
    Injury
    Date Received
    January 4, 2019
    Date of Event
    December 19, 2018
    Report Date
    April 23, 2019
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K151814
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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

    (B)(4)(IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF MAQUET CRITICAL CARE AB (MANUFACTURER). REF. EXEMPTION #: E2018003 (B)(4). THE VENTILATOR WAS NOT INVESTIGATED BY OUR FIELD SERVICE ENGINEER BUT VENTILATOR LOGS WERE PROVIDED FROM THE USER FACILITY. HOWEVER, DUE TO CONTINUOUS USE AFTER THE EVENT, THE REGISTRATIONS FROM THE ACTUAL EVENT DATE WERE OVERWRITTEN IN THE INTERNAL LOG. THE REPORTED FAILURE OF RESTART AFTER DISCONNECT FOR SUCTIONING COULD THEREFORE NOT BE CONFIRMED. AFTER THE VENTILATOR WAS RETURNED TO THE MANUFACTURER, THE VENTILATOR WAS INVESTIGATED. THE VENTILATOR PASSED PRE-USE CHECK. SEVERAL DISCONNECTION/SUCTION PROGRAMS WERE PERFORMED. THE VENTILATOR RESTARTED AFTER EACH PROGRAM. THE REPORTED ISSUE COULD NOT BE REPRODUCED. NO MALFUNCTION WAS FOUND. VENTILATOR LOGS WERE DOWNLOADED AGAIN AND REVIEWED. EVALUATION OF THE DEVICE LOGS SHOW THAT THE VENTILATOR WAS REMAINED IN USE AFTER THE EVENT AND SEVERAL DISCONNECTION/SUCTION PROGRAMS HAD BEEN PERFORMED BETWEEN THE EVENT DATE AND THE RETURN OF THE VENTILATOR. NO FAILURE OF RESTART COULD BE NOTED AFTER ANY OF THESE PROGRAMS. THE LOGS ALSO CONTAINED SEVERAL SUCCESSFUL PRE-USE CHECKS BETWEEN THE EVENT DATE AND THE RETURN OF THE VENTILATOR. NO TECHNICAL ERROR CODES HAVE BEEN GENERATED TO INDICATE THAT THERE WAS A VENTILATOR MALFUNCTION AT THE TIME OF THE EVENT OR AFTERWARDS. THE ISSUE WITH NOT DETECTING RECONNECTION AFTER SUCTION PROGRAM CAN BE REPRODUCED BY INTRODUCING A LARGE LEAKAGE DURING DISCONNECTING. AT RECONNECT AFTER SUCTION PROGRAM IS ENDED AND IF THERE IS A LARGE LEAKAGE, THE FLOW OR PRESSURE WILL THEN NOT REACH THE LIMIT WHICH TRIGGER THE VENTILATOR TO START. THIS WILL BE DIFFICULT FOR THE VENTILATOR TO DETECT AS A LARGE LEAKAGE CANNOT BE DISTINGUISHED FROM THE ACTUAL DISCONNECT. IT IS ALSO POSSIBLE TO RESTART VENTILATION MANUALLY BY TAPPING START VENTILATION ON THE USER INTERFACE. A LEAKAGE SITUATION IS NOT A VENTILATOR MALFUNCTION. IT HAS NOT BEEN DETERMINED IF THERE WAS A LEAKAGE DURING THE DISCONNECTION. OUR CONCLUSION IS THAT THERE WAS NO VENTILATOR MALFUNCTION AT THE TIME OF THE EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER THE PATIENT WAS MANUALLY DISCONNECTED FROM THE VENTILATOR FOR SUCTIONING THERE WAS A FAILURE OF VENTILATION TO RECOMMENCE. CLINICAL CHANGE IN PATIENT CONDITION WAS OBSERVED: DETERIORATION IN HEART RATE AND OXYGEN SATURATION. NEOPUFF RESUSCITATION WAS REQUIRED. FINAL PATIENT OUTCOME WAS NO INJURY. MANUFACTURER REF. #: (B)(4).

    Description of Event or Problem · 0

    MANUFACTURER REF. #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11726 SERVO-N VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening