BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-N

    MDR report key: 8565123 · Received April 30, 2019

    Report

    Report Number
    8010042-2019-00293
    Event Type
    Malfunction
    Date Received
    April 30, 2019
    Date of Event
    April 11, 2019
    Report Date
    September 4, 2019
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K180098
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC
    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).

    Additional Manufacturer Narrative · 0

    THE VENTILATOR WAS INVESTIGATED ON-SITE BY OUR FIELD SERVICE ENGINEER (FSE). THE REPORTED ALARMS FOR HIGH O2 CONCENTRATION COULD NOT BE REPLICATED. THE NOZZLE UNITS IN THE GAS MODULES WERE PRECAUTIONARY REPLACED BUT NOT RETURNED FOR INVESTIGATION. THE SYSTEM SOFTWARE WAS REINSTALLED, FUNCTIONAL CHECKS WERE PERFORMED WITH SUCCESSFUL RESULTS AND THE VENTILATOR WAS CLEARED FOR CLINICAL USE. SINCE THE SYSTEM SOFTWARE WAS REINSTALLED, NO LOGS FROM THE REPORTED EVENT DATE COULD BE PROVIDED DUE TO THAT THE LOG POSTS PRIOR TO THE SYSTEM SOFTWARE DOWNLOAD HAD BEEN ERASED PER DESIGN. THE REPORTED TANDEM USE OF A HFJV IMPLIES THAT THE HFJV IS CONNECTED TO AN ET TUBE ADAPTER AND IT INDUCES A ¿JET¿ OF GAS OUT OF THE ADAPTER INTO THE AIRWAY. THE MEASURED INSPIRATORY VALUES WOULD BE AS PER THE SET PARAMETER VALUES BUT THE MEASURED EXPIRATORY VALUES WOULD INCLUDE THE VALUES OF THE HFJV AND THEREFORE, THE MEASURED EXPIRATORY VALUES WOULD NOT REFLECT THE PARAMETER SETTINGS AND WILL LEAD TO GENERATION OF APPROPRIATE ALARMS, FOR EXAMPLE HIGH O2 CONCENTRATION. THE USE OF A HFJV IN TANDEM WITH THE VENTILATOR HAS NOT BEEN TESTED, APPROVED, OR RECOMMENDED FOR USE WITH THIS VENTILATOR SYSTEM. THEREFORE THE CONSEQUENCES OF ITS USE WITH OUR VENTILATOR ARE UNKNOWN. AS NO LOG FILES FROM EVENT DATE WERE PROVIDED AND NO PARTS WERE RETURNED FOR OUR INVESTIGATION, IT HAS NOT BEEN POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE REPORTED EVENT BUT THE USE OF HFJV IN TANDEM WITH THE VENTILATOR IS THE MOST LIKELY CONTRIBUTING FACTOR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PATIENT TREATMENT, THE MEASURED O2 CONCENTRATION WAS HIGHER THAN SET WHEN THE VENTILATOR WAS RUN IN TANDEM WITH A HIGH FREQUENCY JET VENTILATOR (HFJV). THERE WAS NO PATIENT HARM. (B)(4).

    Description of Event or Problem · 0

    IMPORTER REF. #: CC-CPL-2019-00823. MANUFACTURER REF. #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359279 SERVO-N VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1