BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-U

    MDR report key: 7677026 · Received July 11, 2018

    Report

    Report Number
    8010042-2018-00348
    Event Type
    Malfunction
    Date Received
    July 11, 2018
    Date of Event
    June 16, 2018
    Report Date
    September 11, 2018
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K151814
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 PERON: PEDRO CRUZ.

    Additional Manufacturer Narrative · 0

    THE VENTILATOR WAS INVESTIGATED BY THE DISTRIBUTOR AND THE NOZZLE UNITS IN THE GAS MODULES WERE REPLACED. THE VENTILATOR WAS THEN FUNCTIONING. SEVERAL REQUESTS FOR RETURNING THE NOZZLE UNITS WERE SENT BUT THEY WERE NOT RETURNED FOR INVESTIGATION. 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. REVIEW OF PROVIDED VENTILATOR LOGS CONFIRMS THE REPORTED ALARMS FOR HIGH AIRWAY PRESSURE IN COMBINATION WITH ALARMS FOR HIGH O2 CONCENTRATION. SINCE THE NOZZLE UNIT WAS NOT 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 WHEN CONNECTED TO A PATIENT, THE VENTILATOR GENERATED ALARMS FOR HIGH O2 CONCENTRATION AND HIGH PRESSURE. THERE WAS NO PATIENT HARM. (B)(4).

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522453 SERVO-U VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1