BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 8090943 · Received November 20, 2018

    Report

    Report Number
    8010042-2018-00615
    Event Type
    Malfunction
    Date Received
    November 20, 2018
    Date of Event
    June 9, 2018
    Report Date
    January 16, 2019
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K123149
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    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

    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). THE VENTILATOR WAS NOT INVESTIGATED BY OUR FIELD SERVICE ENGINEER. NO SERVICE HAS BEEN REQUESTED BY THE USER FACILITY. NO PARTS HAVE BEEN RETURNED FOR INVESTIGATION. PROVIDED VENTILATOR LOGS WERE REVIEWED. ALARMS FOR HIGH PEEP WERE GENERATED IN COMBINATION WITH HIGH AIRWAY PRESSURE, LOW EXPIRATORY MINUTE VOLUME AND HIGH RESPIRATORY RATE ALARMS. THE GENERATED ALARMS INDICATE A HIGH EXPIRATORY RESISTANCE. AT HIGH EXPIRATORY RESISTANCE, THE PATIENT DOES NOT HAVE TIME TO BREATHE PROPERLY DURING THE EXPIRATORY PHASE BEFORE A NEW BREATH IS INITIATED. THIS LEADS TO A HIGHER PEEP VALUE THAN THE PRE-SET AND ALARMS FOR HIGH AIRWAY PRESSURE ARE GENERATED. THE DIFFICULTIES MAY EITHER BE DUE TO NON-OPTIMAL USER SETTINGS OF THE DEVICE FOR THE ACTUAL PATIENT OR AN INCREASED EXPIRATORY RESISTANCE DUE TO ACCESSORIES IN THE PATIENT CIRCUIT. INFORMATION CONCERNING WHAT TYPE OF PATIENT BREATHING CIRCUIT OR FILTER THAT WAS IN USE AT THE TIME OF EVENT WAS NOT PROVIDED. NO PRE-USE CHECK WAS PERFORMED BEFORE VENTILATION WAS STARTED. THE LAST PRE-USE CHECK WAS PERFORMED 14 DAYS PRIOR TO USE. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PATIENT TREATMENT, THE VENTILATOR WAS CONTINUOUSLY ALARMING AND DID NOT SEEM TO DELIVER ANY BREATHS. THERE WAS NO PATIENT HARM. (B)(4).

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    932787 SERVO-I VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1