BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-U

    MDR report key: 7832421 · Received August 30, 2018

    Report

    Report Number
    8010042-2018-00454
    Event Type
    Malfunction
    Date Received
    August 30, 2018
    Date of Event
    August 21, 2018
    Report Date
    October 8, 2018
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K151814
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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

    NO SERVICE ON THE VENTILATOR HAS BEEN REQUESTED BY THE HOSPITAL. A RECOMMENDATION HAS BEEN GIVEN TO REPLACE THE NOZZLE UNITS AND/OR THE GAS MODULES. THERE IS NO INFORMATION IF ANY PARTS HAVE BEEN REPLACED. THE INVESTIGATION OF THE PROVIDED VENTILATOR LOGS CONFIRMS THE REPORTED EVENT OF ALARMS FOR LOW O2 CONCENTRATION. THE LOGS DO NOT CONTAIN ANY TECHNICAL ERROR CODES INDICATING ANY VENTILATOR MALFUNCTION AT THE TIME OF THE EVENT. PRE-USE CHECK WAS SUCCESSFULLY PERFORMED BOTH PRIOR AND AFTER THE EVENT DATE. THE NOZZLE UNIT IS PART OF THE GAS MODULE AND REGULATES THE INSPIRATORY GAS FLOW TO THE PATIENT. IT CONSISTS OF A MEMBRANE, A MOUTHPIECE AND A FEATHER SPRING. THE MEMBRANE IN THE NOZZLE UNIT IS PRESSED AGAINST A MOUTHPIECE WITH A FEATHER SPRING TO REGULATE THE GAS FLOW THROUGH THE GAS MODULE. SINCE NO PARTS WERE RETURNED FOR INVESTIGATION, THE ROOT CAUSE OF THE REPORTED ALARMS HAS NOT BEEN DETERMINED, BUT THE NOZZLE UNIT WAS MOST LIKELY CONTRIBUTING TO THE EVENT. THE NOZZLE UNIT IS PART OF THE MAINTENANCE KIT FOR THE PRODUCT AND SHALL BE REPLACED YEARLY OR BY MAXIMUM 5000 OPERATING HOURS. IT IS NOT KNOWN TO US WHEN LAST MAINTENANCE WAS PERFORMED.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 WHILE CONNECTED TO A PATIENT, THE VENTILATOR ALARMED FOR LOW O2 CONCENTRATION. 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
    672447 SERVO-U VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1