BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-U

    MDR report key: 7625609 · Received June 21, 2018

    Report

    Report Number
    8010042-2018-00308
    Event Type
    Malfunction
    Date Received
    June 21, 2018
    Date of Event
    May 30, 2018
    Report Date
    August 9, 2018
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K151814
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 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 (B)(4). CONTACT PERON: (B)(4). THE VENTILATOR WAS INVESTIGATED ON-SITE BY OUR FIELD SERVICE ENGINEER. THE EXPIRATORY CASSETTE WAS REPLACED WITH A KNOWN GOOD EXPIRATORY CASSETTE. THE VENTILATOR THEN PASSED ALL FUNCTIONAL AND SAFETY TESTS AND WAS CLEARED FOR CLINICAL USE. NO PARTS WERE RETURNED FOR INVESTIGATION. PROVIDED LOG FILES DID NOT INCLUDE THE REPORTED EVENT DATE. CORRECT LOG FILES WERE REQUESTED BUT NOT PROVIDED. SCREEN PHOTOS OF LOGS FROM THE REPORTED DATE AND TIME WERE PROVIDED. THE PHOTOS CONFIRM SEVERAL ALARMS HAVE BEEN GENERATED AS AN INDICATION OF DIFFICULTIES WITH VENTILATING THE PATIENT TO AND FROM DURING THE PERIOD WHEN THE USER FACILITY STATES THAT THE EVENT HAS OCCURRED. THOSE ALARMS INDICATE THAT THE VENTILATOR WAS FUNCTIONING AND IT ATTEMPTED TO DELIVER THE VENTILATOR SUPPORT USING THE PRESET PRESSURE LEVEL BUT IT FAILED DUE TO THE IMPOSED RESTRICTION OF THE SET UPPER PRESSURE LIMIT. THE ALARM FOR EXPIRATORY CASSETTE ERROR WAS ALSO GENERATED INDICATING A TECHNICAL PROBLEM WITH THE EXPIRATORY CASSETTE. THE VENTILATION DIFFICULTIES MAY EITHER BE RELATED TO NOT OPTIMAL USER SETTINGS OF THE DEVICE FOR THE ACTUAL PATIENT OR AN INCREASED EXPIRATORY RESISTANCE IN THE PATIENT¿S BREATHING SYSTEM WHERE THE EXPIRATORY CASSETTE IS ONE COMPONENT. SINCE NO PARTS WERE RETURNED FOR INVESTIGATION, THE ROOT CAUSE HAS NOT BEEN DETERMINED, BUT THE REPLACED EXPIRATORY CASSETTE IS MOST LIKELY THE CAUSE OF THE VENTILATION DIFFICULTIES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING VENTILATOR TREATMENT, THE VENTILATOR SYSTEM GENERATED DIFFERENT ALARMS, INDICATING INSUFFICIENT VENTILATION TO PATIENT. IT WAS ALSO REPORTED THAT THE VENTILATOR HAD TECHNICAL ALARMS RELATED TO THE EXPIRATORY CASSETTE. THE VENTILATOR WAS REPLACED. THERE WAS NO PATIENT HARM REPORTED. (B)(4).

    Description of Event or Problem · 0

    MANUFACTURER REFERENCE#: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468203 SERVO-U VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1