BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-U

    MDR report key: 8715623 · Received June 20, 2019

    Report

    Report Number
    8010042-2019-00423
    Event Type
    Malfunction
    Date Received
    June 20, 2019
    Date of Event
    May 18, 2019
    Report Date
    August 30, 2019
    Product Code
    CBK
    PMA / PMN Number
    K180098
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    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

    THE VENTILATOR WAS INVESTIGATED ON SITE AND THE O2 AND AIR GAS MODULE WAS REPLACED AND RETURNED FOR INVESTIGATION. ROBUSTNESS TESTING OF THE RECEIVED O2 AND AIR GAS MODULE HAS REPRODUCED THE DESCRIBED CUSTOMER ISSUE. EVALUATION OF THE RECEIVED DEVICE LOGS SHOWS A MATCHING EVENT BETWEEN (B)(6) 18, AT 17:26 AND (B)(6) , AT 00:41, SEVERAL ALARMS FOR HIGH O2 CONCENTRATION WERE GENERATED. A PRE-USE CHECK WAS CONFIRMED TO BE SUCCESSFUL PRIOR TO THIS VENTILATION PERIOD. IF THIS FAULT HAPPENS DURING VENTILATION, THE PATIENT MAY RECEIVE AN AMOUNT OF OXYGEN IN THE GAS MIXTURE THAT DEVIATE FROM THE EXPECTED. FLOW AND PRESSURE MAY ALSO DEVIATE FROM THE EXPECTED. ALARMS WILL BE ACTIVATED IF THE FAILURE OCCURS DURING VENTILATION. OUR INVESTIGATION HAS CONCLUDED THAT THE MOST PROBABLE CAUSE OF THE GIVEN ALARMS IS TRACED TO INTERACTION OF SEVERAL PARTS WITHIN THE OXYGEN GAS MODULE, WHERE CONCLUDED THAT THE SOLENOID HAS A CONTRIBUTING EFFECT TO THIS BEHAVIORS, BUT THE ROOT CAUSE HAS NOT YET BEEN FULLY ESTABLISHED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE VENTILATOR ALARMED FOR HIGH O2 CONCENTRATION. THERE WAS NO PATIENT HARM. (B)(4).

    Description of Event or Problem · 0

    MANUFACTURER REF. #: 213538.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    511121 SERVO-U VENTILATOR, CONTINUOUS, FACILITY USE CBK

    Patients

    Seq Age Sex Outcome Treatment
    1