BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERVO-U

    MDR report key: 7772940 · Received August 10, 2018

    Report

    Report Number
    8010042-2018-00417
    Event Type
    Injury
    Date Received
    August 10, 2018
    Report Date
    February 26, 2019
    Manufacturer
    MAGNUS LINDQVIST
    Product Code
    CBK
    PMA / PMN Number
    K151814
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    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

    MAQUET MEDICAL SYSTEMS,USA (IMPORTER) SUBMITS THIS REPORT ON BEHALF OF THE LEGAL MANUFACTURER OF THE DEVICE MAQUET CARDIOPULMONARY AG KEHLER STRASSE 31, 76437 RASTATT, GERMANY. A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. REFERENCE EXEMPTION #: E2018002. IMPORTER- MAQUET MEDICAL SYSTEMS USA 45 BARBOUR POND DRIVE WAYNE, NJ 07470. CONTACT PERSON: (B)(4). ADDITIONAL INFORMATION THAT WAS RECEIVED FROM THE USER STATES THAT THE DAY AFTER THE EVENT THE USER REPRODUCED THE REPORTED FAILURE DURING SIMULATED USE TEST OF THE VENTILATOR WITH THE BREATHING CIRCUIT USED AT THE TIME OF THE EVENT. THE USER DETERMINED THAT THE CAUSE OF THE FAILURE WAS THE EXPIRATORY FILTER THAT WAS OCCLUDED. THE EXPIRATORY FILTER IS NOT MANUFACTURED OR DISTRIBUTED BY US. OUR FIELD SERVICE ENGINEER WAS DISPATCHED TO THE SITE FOR INVESTIGATION OF THE DEVICE. NO FAULT WAS FOUND AND NO PARTS WERE REPLACED. THE DEVICE LOGS WERE DOWNLOADED AND THE VENTILATOR WAS RETURNED BACK FOR CLINICAL USE. EVALUATION OF THE RECEIVED DEVICE LOG SHOWS THAT PRE-USE CHECK PRIOR TO AND AFTER THE EVENT WAS SUCCESSFULLY PERFORMED. THE LOGS INCLUDING THE TREND LOG CONFIRMS A HIGH AIRWAY PRESSURE SITUATION DURING THE LAST HOURS OF VENTILATION. THE HIGH MEASURED PEEP IS AN INDICATION OF THAT THE PATIENT WAS NOT ABLE TO COMPLETE EXHALE DURING EXPIRATION DUE TO AN INCREASED EXPIRATORY RESISTANCE. THIS SITUATION LEADS TO THAT A LOWER TIDAL VOLUME THAN INTENDED CAN BE INSPIRED. OUR CONCLUSION, BASED ON THE INFORMATION RECEIVED FROM CUSTOMER AND EVALUATION OF THE RECEIVED DEVICE LOGS, IS THAT THE CAUSE OF THE EVENT WAS AN OCCLUDED EXPIRATORY FILTER. THERE WAS NO TECHNICAL FAILURE WITH THE VENTILATOR AT THE TIME OF EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE THE VENTILATOR WAS CONNECTED TO A PATIENT, THE PATIENT BEGAN TO HAVE INCREASING ETCO2 TO THE 70-90S, STACKING BREATHS AND TOTAL PEEP FROM AUTO PEEP. IT WAS FURTHER STATED THAT IT APPEARED AS IF THE VALVE WAS NOT OPENING TO ALLOW EXHALATION. THE MEASURED TIDAL VOLUME WAS HALF THE INHALED VOLUME. THE PATIENTS PH WAS 7.19 AND CO2 WAS 95. THE VENTILATOR WAS DISCONNECTED FROM THE PATIENT AND THE PATIENT WAS BAGGED. THE VENTILATOR WAS REPLACED WITH ANOTHER ONE. VENTILATION WITH THE NEW VENTILATOR WITH SAME SETTINGS WAS WITHOUT ANY PROBLEMS AND THE PATIENT WAS BREATHING COMFORTABLY. THE PATIENTS ETCO2 DECREASED TO THE 50S. THE FINAL PATIENT OUTCOME WAS NO INJURY. (B)(4).

    Description of Event or Problem · 0

    MANUFACTURER REFERENCE#: (B)(4). IMPORTER REFERENCE #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    615514 SERVO-U VENTILATOR, CONTINUOUS, FACILITY USE CBK MAGNUS LINDQVIST

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening