BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 8025622 · Received October 31, 2018

    Report

    Report Number
    8010042-2018-00584
    Event Type
    Malfunction
    Date Received
    October 31, 2018
    Date of Event
    October 10, 2018
    Report Date
    November 28, 2018
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K123149
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    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 (B)(4). CONTACT PERON: (B)(4). THE CUSTOMER DID NOT REQUEST ANY SERVICE. WE ARE NOT INFORMED ABOUT ANY REPLACED PART AND HAVE NOT RECEIVED ANY PART FOR OUR INVESTIGATION. NO INFORMATION REGARDING THE CURRENT STATUS OF THE VENTILATOR HAS BEEN COMMUNICATED. THE VENTILATOR LOGS WERE DOWNLOADED FOR FURTHER EVALUATION. THE EVENT LOG CONFIRMS SEVERAL CLINICAL ALARMS, AS AN INDICATION OF DIFFICULTIES WITH VENTILATING THE PATIENT. HOWEVER, THE TECHNICAL LOG DID NOT CONTAIN ANY TECHNICAL ERROR CODES THAT COULD INDICATE A MALFUNCTION. THE LOGS ALSO SHOW THAT THE VENTILATOR ALARMS FOR HIGH AIRWAY PRESSURE, PRESSURE DELIVERY RESTRICTED AND EXPIRATORY MINUTE VOLUME LOW. THE LOGS SHOW THAT THE UNIT WAS RUN ON PRVC (PRESSURE REGULATED VOLUME CONTROL) MODE AT THE TIME OF THE 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. THE HIGH PRESSURE 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.

    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

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE VENTILATOR ALARMED FOR HIGH PRESSURE. THERE WAS NO PATIENT INVOLVEMENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    863051 SERVO-I VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1