BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 7927219 · Received October 2, 2018

    Report

    Report Number
    8010042-2018-00514
    Event Type
    Malfunction
    Date Received
    October 2, 2018
    Report Date
    December 11, 2018
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K123149
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL
    Reporter Occupation
    RISK MANAGER

    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 PERSON: (B)(4).

    Additional Manufacturer Narrative · 0

    THE VENTILATOR WAS FOUND WITH NO FAULT AND NO PARTS WERE REPLACED. AN EVENT LOG FROM THE VENTILATOR THAT CONTAINS THE VENTILATION PERIOD WAS RECEIVED. THE EVENT LOG CONTAINS THE VENTILATION PERIOD DURING WHICH THE EVENT IS ALLEGED TO HAVE OCCURRED. THE EVENT LOG SHOWS THAT THERE WERE NO ALARMS OR OPERATOR INTERACTION DURING THE GIVEN TIME OF THE EVENT. THE FIRST INTERACTION WAS THE INCREASING OF THE OXYGEN CONCENTRATION AFTER THE EVENT AND THE GENERATION OF ALARMS INDICATING LEAKAGE AFTERWARDS. BASING ON THE REPORTED SEQUENCE OF EVENTS AND THE EVENT LOG THE REPORTED EVENT MOST PROBABLY OCCURRED AS REPORTED. THE PRONGS GOT OUT OF THE PATIENT¿S NOSE BUT WERE STILL ATTACHED TO THE VENTILATOR¿S TUBING AND NO ALARMS WERE GENERATED AT THIS TIME. THE ALARMS INDICATING LEAKAGE WERE GENERATED LATER WHEN THE PRONGS GOT DETACHED FROM THE VENTILATOR¿S TUBING. THERE WAS NO VENTILATOR MALFUNCTION AT THE TIME. THE CAUSE WAS THE RESISTANCE IN THE PRONGS IN COMBINATION WITH SMALL VOLUMES AND THE SET ALARM LIMITS. THE LOWER EXPIRATORY MINUTE VOLUME ALARM LIMIT WAS NEAR ZERO AND THE RESISTANCE IN THE PRONGS LED TO PARTIAL LEAKAGE. WHEN TOTAL LEAKAGE OCCURRED THE DISCONNECTION WAS DETECTED AND ALARMS WERE GENERATED. BY OBSERVING THE DISPLAYED CURVES AND THE DIFFERENCE BETWEEN THE MEASURED INSPIRED AND EXPIRED TIDAL VOLUMES, APPROPRIATE ALARM LIMITS CAN BE SET AND A DISCONNECTION IF IT OCCURS WILL LEAD TO GENERATION OF ALARMS. EXEMPTION #: (B)(4). GETINGE USA SALES, LLC (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF MAQUET CRITICAL CARE AB (MANUFACTURER). REF. EXEMPTION #: E2018003. GETINGE USA SALES, LLC (B)(4). CONTACT PERSON: (B)(4).

    Description of Event or Problem · 0

    A USER FACILITY MEDWATCH (REF # (B)(4)) WAS RECEIVED STATING THAT: "INFANT HAD EPISODE WHERE HR DROPPED INTO 60'S. O2 SAT DROPPED INTO 70%'S. STAFF NOTICED (NIPPV) PRONGS WERE OUT OF PTS NOSE. PRONGS WERE PLACED BACK INTO NOSE, UNWRAPPED, AND STIMULATED PT BECAUSE APNEA NOTICED. INFANTS VITALS CONTINUED TO TREND DOWNWARD. STAFF CONTINUED TO GIVE 100% FIO2, SAT UP INFANT, PERFORMED ORAL SUCTION, AND STIMULATED VIGOROUSLY. AT THAT TIME, O2 SATURATION INCREASED TO 16% AND HR WAS 60-80 BPM. STAFF GOT BAG AND VALVE TO START PPV. STARTED TO REMOVE NIPPV PRONGS FROM NOSE AND NOTICED PRONGS NOT ATTACHED TO TUBING CONNECTED TO THE VENT. VENT DID NOT ALARM TO ALERT STAFF TO THE DISCONNECTION AS IT USUALLY DOES. PRONGS RECONNECTED TO TUBING THAT WAS ATTACHED TO VENT." (B)(4).

    Description of Event or Problem · 0

    MANUFACTURER REFERENCE#:(B)(4). IMPORTER REFERENCE #:(B)(4). USER FACILITY MEDWATCH#:(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    769387 SERVO-I VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO Other