BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-U

    MDR report key: 8682491 · Received June 10, 2019

    Report

    Report Number
    8010042-2019-00369
    Event Type
    Malfunction
    Date Received
    June 10, 2019
    Report Date
    October 29, 2019
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K180098
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED TANDEM USE OF A HIGH FREQUENCY JET VENTILATOR (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. PROBLEM CODE: 4117.

    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).

    Description of Event or Problem · 0

    MANUFACTURER'S REF # : (B)(4).

    Description of Event or Problem · 0

    A USER FACILITY MEDWATCH REFERENCE # (B)(4) WAS RECEIVED STATING THAT: "NICU INFANT (PREEMIE) ON JET AND SERVO. ON SERVO VENTILATOR WHEN THE FIO2 WAS ON 45% AND THE MEASURED FIO2 READINGS WAS 50%. THERE WAS AN ALARM FOR HIGH O2 CONCENTRATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476532 SERVO-U VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR