BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-U

    MDR report key: 7337606 · Received March 14, 2018

    Report

    Report Number
    8010042-2018-00129
    Event Type
    Malfunction
    Date Received
    March 14, 2018
    Date of Event
    February 17, 2018
    Report Date
    April 25, 2018
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K151814
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE VENTILATOR WAS INVESTIGATED BY OUR FIELD SERVICE ENGINEER (FSE). ALARMS FOR LOW O2 CONCENTRATION WERE VERIFIED. THE O2 SENSOR WAS REPLACED AS RECOMMENDED IN THE SERVICE MANUAL. THE O2 SENSOR IS A MEASURING DEVICE FOR THE INSPIRED O2 CONCENTRATION. THE VENTILATOR PASSED ALL SAFETY AND FUNCTIONAL TESTS AND WAS CLEARED FOR CLINICAL USE. 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. 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 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. 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).

    Description of Event or Problem · 0

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HIGH FREQUENCY JET VENTILATOR (HFJV) WAS USED IN TANDEM WITH THE VENTILATOR ON A PATIENT. IT WAS NOTED THAT THE O2 CONCENTRATION WAS FLUCTUATING. THERE WAS NO PATIENT HARM. IMPORTER REF. #: (B)(4). MANUFACTURER REF. #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179910 SERVO-U VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1