BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-U

    MDR report key: 7609656 · Received June 18, 2018

    Report

    Report Number
    8010042-2018-00297
    Event Type
    Malfunction
    Date Received
    June 18, 2018
    Date of Event
    June 3, 2018
    Report Date
    October 8, 2018
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    151814
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    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 HOSPITAL PERFORMED PREVENTIVE MAINTENANCE ON THE VENTILATOR SYSTEM, INCLUDING EXCHANGE OF THE NOZZLE UNITS. THE DEVICE WAS SENT BACK TO CLINICAL USAGE AND STARTED THEREAFTER ALARMING FOR O2 CONCENTRATION HIGH, AS STATED IN THE PROBLEM DESCRIPTION. THE DEVICE WAS SENT BACK TO HOSPITAL BIOMED FOR INVESTIGATION WITHOUT FINDING ANY TECHNICAL PROBLEMS OF THE DEVICE. EVALUATION OF THE RECEIVED DEVICE LOGS SHOWS THAT THE MATCHING EVENT COULD BE TRACED BACK TO JUNE 3, THERE WAS NO INITIAL INFORMATION PROVIDED ABOUT EVENT DATE. ON JUNE 3RD DURING THE TIME PERIOD 07:17 TO 12:07, THE SET VALUE FOR O2 CONCENTRATION WAS 55% AND 50% AND THE MEASURED OXYGEN CONCENTRATION WAS FLUCTUATING APPROXIMATELY BETWEEN 50-61%, WHICH IS CONSIDERED TO BE A MINOR DEVIATION. THE FLUCTUATION OF O2 CONCENTRATION MADE THE DEVICE TO GENERATE ALARMS ACCORDINGLY TO DESIGN. THE PRE-USE CHECK WAS CONFIRMED TO BE SUCCESSFUL BOTH BEFORE AND AFTER THE EVENT. BASED ON THE DEVICE LOG EVALUATION OUR CONCLUSION IS THAT THE PROBLEM WAS INTERMITTENT CHARACTERISTIC AND THAT THE EVENT WAS LIKELY CAUSED BY THE NOZZLE UNITS RECENTLY INSTALLED BY THE HOSPITAL BIOMED. 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).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE VENTILATOR ALARMED FOR HIGH AND LOW O2 CONCENTRATIONS 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
    451511 SERVO-U VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1