BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-U

    MDR report key: 7855071 · Received September 7, 2018

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    Report

    Report Number
    8010042-2018-00469
    Event Type
    Malfunction
    Date Received
    September 7, 2018
    Date of Event
    July 4, 2018
    Report Date
    November 7, 2018
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K151814
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    THE VENTILATOR WAS INVESTIGATED ON SITE BY OUR FIELD SERVICE ENGINEER (FSE) AND THE O2-SENSOR WAS REPLACED AND RETURNED FOR INVESTIGATION. THE O2-SENSOR IS MEASURING THE OXYGEN CONCENTRATION TO THE PATIENT. THE REPORTED ALARM FOR LOW O2-CONCENTRATION WAS REPRODUCED DURING TEST OF THE RETURNED O2-SENSOR IN A VENTILATOR. THE O2-SENSOR WAS RE-CALIBRATED IN THE O2-CELL/SENSOR SUBTEST IN THE PRE-USE CHECK AND THEN THE O2-SENSOR WAS WORKING AS EXPECTED. THAT INDICATES THAT CONCENTRATION IN THE SUPPLIED AIR AND/OR OXYGEN GASES IN THE HOSPITAL WERE NOT WITHIN OUR RECOMMENDED SPECIFICATION AT THE TIME. EVALUATION OF THE RECEIVED DEVICE LOGS SHOWS THAT THE MATCHING EVENT ON THE REPORTED DAY DURING THE TIME PERIOD 15:18 TO 16:57, HAD SEVERAL ALARMS FOR LOW O2 CONCENTRATION. THE PRE-USE CHECK WAS CONFIRMED TO BE SUCCESSFUL BOTH BEFORE AND AFTER THE EVENT. 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).

    Description of Event or Problem · 0

    (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE CONNECTED TO A PATIENT, THE VENTILATOR ALARMED FOR LOW O2 CONCENTRATION. THERE WAS NO PATIENT HARM. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695303 SERVO-U VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1