BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 8189143 · Received December 21, 2018

    Report

    Report Number
    8010042-2018-00698
    Event Type
    Malfunction
    Date Received
    December 21, 2018
    Date of Event
    December 18, 2018
    Report Date
    February 19, 2019
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K123149
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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

    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). THE VENTILATOR WAS INVESTIGATED AT SITE BY OUR FIELD SERVICE ENGINEER. NO DEVICE ERRORS COULD BE DETECTED AND NO PARTS WERE REPLACED. THE VENTILATOR PASSED ALL FUNCTIONAL AND SAFETY TESTS AND WAS CLEARED FOR CLINICAL USE. VENTILATOR LOGS WERE DOWNLOADED. THE EVALUATION OF THE LOGS SHOWS THAT THE REPORTED ALARMS FOR PEEP HIGH OCCURRED ON THE REPORTED EVENT DATE. NEBULIZATION OF MEDICATION WAS USED DURING THE PATIENT TREATMENT AND IT WAS NOTED THAT THE ALARMS FOR PEEP HIGH OCCURRED AFTER SEVERAL NEBULIZATION PERIODS HAVE BEEN PERFORMED. ADDITIONAL INFORMATION FROM THE USER FACILITY STATED THAT A NON-COMPATIBLE HUMIDIFIER WAS USED TOGETHER WITH AN EXPIRATORY BACTERIAL FILTER FROM ANOTHER BRAND. THE ALARMS ALONG WITH INFORMATION ABOUT THE HUMIDIFIER AND FILTER IN USE WITH NEBULIZATION AND ACTIVE HUMIDIFICATION INDICATE AN INCREASED EXPIRATORY RESISTANCE IN THE PATIENT¿S BREATHING SYSTEM. ONE POSSIBLE CAUSE IS AN OCCLUDED EXPIRATORY BACTERIAL FILTER. INCREASED PRESSURE CAN BE A RESULT FROM A CLOGGED EXPIRATORY BACTERIAL FILTER DURING NEBULIZATION. AS STATED IN THE USER¿S MANUAL, THE AIRWAY PRESSURE SHOULD BE MONITORED DURING NEBULIZATION. THERE ARE NO TECHNICAL ERROR CODES IN THE LOGS, WHICH INDICATE THAT THERE IS NO VENTILATOR MALFUNCTION. SUCCESSFUL PRE-USE CHECKS WERE PERFORMED BOTH PRIOR AND AFTER THE EVENT. 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 EXPIRATORY BACTERIAL FILTER. THERE IS NO INDICATION OF A TECHNICAL FAILURE IN THE VENTILATOR AT THE TIME OF THE EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE VENTILATOR GENERATED ALARMS FOR HIGH PEEP (POSITIVE END EXPIRATORY PRESSURE) DURING PATIENT TREATMENT. THERE WAS NO PATIENT HARM. 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
    1028549 SERVO-I VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1