BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-U

    MDR report key: 8119726 · Received November 30, 2018

    Report

    Report Number
    8010042-2018-00647
    Event Type
    Malfunction
    Date Received
    November 30, 2018
    Date of Event
    November 11, 2018
    Report Date
    January 23, 2019
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K151814
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    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). THE VENTILATOR WAS INVESTIGATED BY OUR FIELD SERVICE ENGINEER (FSE). IT WAS NOT POSSIBLE TO DUPLICATE THE REPORTED EVENT. THE VENTILATOR PASSED ALL SAFETY AND FUNCTIONAL TESTS AND WAS CLEARED FOR CLINICAL USE. THE EVALUATION OF THE LOGS SHOWS, THAT THE REPORTED ALARM FOR APNEA OCCURRED ON THE REPORTED EVENT DATE. VENTILATION WAS STARTED ONE DAY PRIOR. SEVERAL ALARMS FOR HIGH PRESSURE WERE GENERATED DURING THE VENTILATION PERIOD. NEBULIZATION OF MEDICATION WAS USED DURING THE PATIENT TREATMENT AND IT WAS NOTED THAT THE ALARMS FOR HIGH PRESSURE OCCURRED AFTER EACH NEBULIZATION PERIOD. THE GENERATED ALARMS FOR HIGH PRESSURE ARE AN INDICATION OF HIGH RESISTANCE IN THE PATIENT CIRCUIT, WHERE ONE POSSIBLE CAUSE IS AN OCCLUDED EXPIRATORY BACTERIAL FILTER. THE USER¿S MANUAL STATES THAT ¿DURING NEBULIZATION, CAREFULLY MONITOR THE AIRWAY PRESSURE. INCREASED AIRWAY PRESSURE COULD RESULT FROM A CLOGGED FILTER. REPLACE THE FILTER IF THE EXPIRATORY RESISTANCE INCREASES OR AFTER MAXIMUM USAGE TIME ACCORDING TO FILTER SPECIFICATION, WHICHEVER COMES FIRST.¿ INFORMATION HOW LONG THE FILTER WAS IN USE WAS NOT PROVIDED. IN CONCLUSION, NO GOODS SUCH AS USED FILTERS WERE RETURNED. THEREFORE NO FURTHER INVESTIGATION HAS BEEN POSSIBLE. THE EXACT ROOT CAUSE OF THE REPORTED EVENT HAS NOT BEEN DETERMINED BUT MOST PROBABLY IT WAS AN OCCLUDED BACTERIAL FILTER. THERE IS NO INDICATION OF A TECHNICAL FAILURE IN THE VENTILATOR AT THE TIME OF THE EVENT.

    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

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

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    961225 SERVO-U VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1