BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-U

    MDR report key: 8436359 · Received March 20, 2019

    Report

    Report Number
    8010042-2019-00183
    Event Type
    Malfunction
    Date Received
    March 20, 2019
    Date of Event
    March 13, 2019
    Report Date
    September 4, 2019
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K151814
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    NO VENTILATOR LOGS WERE PROVIDED AND NO PARTS WERE RETURNED FOR INVESTIGATION. NO FURTHER INFORMATION WAS PROVIDED BY THE USER FACILITY REGARDING THE USE OF HIGH FREQUENCY JET VENTILATOR (HFJV) IN TANDEM WITH THE VENTILATOR. 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 FLUCTUATING 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 WERE PROVIDED AND NO PARTS WERE REPLACED AND 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.

    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. #: CC-CPL-2019-00572. MANUFACTURER REF. #: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PATIENT TREATMENT, THE DELIVERED O2 CONCENTRATION FROM THE VENTILATOR WAS FLUCTUATING WHILE BEING RUN IN TANDEM WITH A HIGH FREQUENCY JET VENTILATOR (HFJV). THERE WAS NO PATIENT HARM. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228411 SERVO-U VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1