BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-N

    MDR report key: 8422037 · Received March 14, 2019

    Report

    Report Number
    8010042-2019-00167
    Event Type
    Malfunction
    Date Received
    March 14, 2019
    Date of Event
    February 24, 2019
    Report Date
    May 22, 2019
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K151814
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC
    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 PERON: (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). THE VENTILATOR WAS INVESTIGATED ON SITE AND THE NOZZLE UNITS FROM THE O2 AND THE AIR GAS MODULE WAS REPLACED. THE NOZZLE UNITS HAVE NOT BEEN RECEIVED. EVALUATION OF THE RECEIVED DEVICE LOGS SHOWS THAT THE MATCHING EVENT ON FEBRUARY 24 DURING THE TIME PERIOD 06:55 TO 07:20 THE DAY AFTER. IF THIS CONDITION OCCURS DURING VENTILATION, THE PATIENT MAY RECEIVE AN AMOUNT OF OXYGEN IN THE GAS MIXTURE THAT DEVIATE FROM THE EXPECTED AND ALARMS WILL BE ACTIVATED TO THE CONDITION. THE ROOT CAUSE HAS NOT BEEN FULLY ESTABLISHED, BUT OUR CONCLUSION IS THAT IT WAS LIKELY DUE TO THE NOZZLE UNIT, A MAINTENANCE PART OF THE AIR GAS MODULE.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216425 SERVO-N VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1