BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-U

    MDR report key: 8105700 · Received November 27, 2018

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    Report

    Report Number
    8010042-2018-00627
    Event Type
    Malfunction
    Date Received
    November 27, 2018
    Date of Event
    November 14, 2018
    Report Date
    January 21, 2019
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K151814
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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: (B)(4). NO PARTS HAVE BEEN CHANGED ON THE VENTILATOR. THE EVALUATION OF PROVIDED DEVICE LOGS CONFIRMS THE REPORTED EVENT. THE LOGS SHOW THAT THE VENTILATOR ALARMED FOR HIGH O2 CONCENTRATION AND ALSO IN COMBINATION WITH HIGH AIRWAY PRESSURE. ALARMS FOR HIGH O2 CONCENTRATION ARE GENERATED WHEN THE O2 CONCENTRATION BECOMES HIGHER THAN THE UPPER ALARM LIMIT WHICH IS SET VALUE +5 VOL%. ALARMS FOR HIGH AIRWAY PRESSURE INDICATE THAT VENTILATION IS ONGOING BUT WITH HIGHER AIRWAY PRESSURE THAN INTENDED. THERE ARE NO TECHNICAL ERROR CODES THAT INDICATE ANY TECHNICAL ISSUES WITH THE VENTILATOR. PRE-USE CHECK PRIOR VENTILATION WAS STARTED PASSED WITHOUT REMARKS. THE ROOT CAUSE OF THE ALARMS FOR HIGH O2 CONCENTRATION HAS NOT BEEN DETERMINED.

    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).

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE VENTILATOR ALARMED FOR HIGH O2 CONCENTRATION DURING PATIENT TREATMENT. THERE WAS NO PATIENT HARM. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    944927 SERVO-U VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1