BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 7354687 · Received March 20, 2018

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    Report

    Report Number
    8010042-2018-00150
    Event Type
    Malfunction
    Date Received
    March 20, 2018
    Date of Event
    February 22, 2018
    Report Date
    July 31, 2018
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K123149
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 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). ON-SITE INVESTIGATION OF THE VENTILATOR WAS PERFORMED BY OUR FIELD SERVICE ENGINEER. THE O2 GAS MODULE WAS FOUND FAULTY AND WAS REPLACED AND THE VENTILATOR RETURNED FOR CLINICAL USE. THE DEVICE LOGS WERE SAVED. THE O2 GAS MODULE REGULATES THE INSPIRATORY O2 GAS FLOW TO THE PATIENT. THE RETURNED O2 GAS MODULE WAS SIMULATED USE TESTED IN A REFERENCE VENTILATOR. A PRE-USE CHECK WAS PERFORMED THAT PASSED WITHOUT DEVIATIONS. AFTER A FEW HOURS IN VENTILATION MODE THE REPORTED O2 CONCENTRATION HIGH ALARM WAS REPRODUCED. THE NOZZLE UNIT IN THE O2 GAS MODULE WAS REPLACED AND THE O2 GAS MODULE WAS TESTED AGAIN. THE REPORTED O2 CONCENTRATION HIGH ALARM WAS NOT REPRODUCED WITH THE NEW NOZZLE UNIT MOUNTED. THE O2 GAS MODULE WAS ALSO TESTED IN THE PRODUCTION TEST SYSTEM FOR GAS MODULES. IT WAS TESTED BOTH WITH THE ORIGINAL NOZZLE UNIT AND THE NEW NOZZLE UNITS. WITH THE ORIGINAL NOZZLE UNIT MOUNTED OSCILLATIONS WAS OBSERVED AND THESE OSCILLATIONS WERE NOT OBSERVED WITH THE NEW NOZZLE UNIT MOUNTED. THE NOZZLE UNIT HAS A PREDETERMINED LIFETIME AND IS REPLACED AT PREVENTIVE MAINTENANCE (PM) THAT MUST BE PERFORMED EVERY 5000 HOURS OF OPERATION OR AT LEAST ONCE A YEAR. IN THIS CASE THE NOZZLE UNIT HAD FAILED PREMATURELY. THE RECEIVED DEVICE LOGS FOR THE DATE OF EVENT WERE MISSING. THE CONCLUSION IN THE MATTER IS THAT THE NOZZLE UNIT IN THE O2 GAS MODULE WAS THE CAUSE OF THE REPORTED SPORADICALLY HIGH O2 CONCENTRATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE VENTILATOR WAS GIVING SPORADICALLY HIGH O2 CONCENTRATIONS AFTER PROLONGED USE, DURING PATIENT TREATMENT. THE VENTILATOR WAS REPLACED. THERE WAS NO PATIENT HARM. (B)(4).

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194770 SERVO-I VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1