BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-N

    MDR report key: 7685056 · Received July 13, 2018

    Report

    Report Number
    8010042-2018-00354
    Event Type
    Malfunction
    Date Received
    July 13, 2018
    Date of Event
    July 6, 2018
    Report Date
    September 28, 2018
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K151814
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    NO SERVICE ON THE VENTILATOR HAS BEEN REQUESTED BY THE HOSPITAL. NO INFORMATION HAS BEEN RECEIVED REGARDING ANY PARTS REPLACEMENT. THE EVENT LOG CONFIRMS THAT SEVERAL CLINICAL ALARMS HAVE BEEN GENERATED, AS AN INDICATION OF DIFFICULTIES WITH VENTILATING THE PATIENT. THE LOGS SHOW THAT THE VENTILATOR WAS SET TO A PRVC VENTILATION MODE AND THAT ALARMS FOR AIRWAY PRESSURE HIGH AND VOLUME DELIVERY RESTRICTED WERE GENERATED PRIOR AND AFTER THE REPORTED EVENT. THOSE ALARMS INDICATE THAT THE VENTILATOR WAS FUNCTIONING AND IT ATTEMPTED TO DELIVER THE SET TIDAL VOLUMES, BUT IT FAILED DUE TO THE IMPOSED RESTRICTION OF THE SET UPPER PRESSURE LIMIT. IN PRVC VENTILATION MODE THE VENTILATOR DELIVERS A PRE-SET TIDAL VOLUME AND THE PRESSURE IS AUTOMATICALLY REGULATED TO DELIVER THE PRE-SET VOLUME, BUT IT IS LIMITED TO 5 CMH2O BELOW THE SET UPPER PRESSURE LIMIT. THE VOLUME DELIVERY RESTRICTED ALARM IS GENERATED WHEN THE SET VOLUME IS NOT ATTAINED DUE TO THE IMPOSED RESTRICTION OF THE SET UPPER PRESSURE LIMIT (-5 CM H2O). THE AIRWAY PRESSURE HIGH ALARM IS GENERATED WHEN THE UPPER PRESSURE LIMIT IS REACHED WHEREBY THE INSPIRATION PHASE IS TERMINATED AND GOES OVER TO EXPIRATION PHASE. THE DIFFICULTIES MAY EITHER BE RELATED TO NOT OPTIMAL PARAMETER SETTINGS OF THE DEVICE FOR THE ACTUAL PATIENT CONDITION OR AN INCREASED EXPIRATORY RESISTANCE. SUCCESSFUL PRE-USE CHECKS WERE PERFORMED PRIOR TO USE. THE TECHNICAL LOG DID NOT CONTAIN ANY TECHNICAL ERROR CODES THAT COULD INDICATE A MALFUNCTION OF THE VENTILATOR. THE CAUSE OF THE REPORTED PROBLEM IS ATTRIBUTED TO USER ERROR OR CLINICAL APPLICATION ERROR. THERE IS NO INDICATION OF A VENTILATOR MALFUNCTION AT THE TIME OF THE EVENT. 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

    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).

    Description of Event or Problem · 0

    (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN THE VENTILATOR WAS CONNECTED TO A PATIENT, SPIKES WERE NOTED ON THE PRESSURE WAVEFORMS ON THE MONITOR. THERE WAS NO PATIENT HARM. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530320 SERVO-N VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1