BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-U

    MDR report key: 8335368 · Received February 13, 2019

    Report

    Report Number
    8010042-2019-00086
    Event Type
    Malfunction
    Date Received
    February 13, 2019
    Report Date
    March 29, 2019
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K151814
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    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

    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). THE FIELD SERVICE ENGINEER (FSE) WAS ON SITE AND INVESTIGATED THE REPORTED ISSUE. NO PARTS WERE REPLACED AND THE UNIT PASSED ALL FUNCTIONAL AND SAFETY TESTS, RETURNED TO CLINICAL USE. THE RECEIVED INTERNAL LOG SHOWS THAT THE VENTILATOR GENERATED ALARMS ACCORDINGLY DUE TO THE HOSPITAL GAS SUPPLY FAILURE, WHICH CAN BE OBSERVED IN THE TEST LOGS. THE UNIT PASSED PRE-USE CHECK BEFORE, AFTER AND DURING THE EVENT/S, HOWEVER IT FAILED GAS SUPPLY TEST AND THIS LED TO LEAKAGE. THE ROOT CAUSE RELATED TO FACILITY GAS SUPPLY FAILURE AND THERE IS NO VENTILATOR MALFUNCTION. THE LOGS ALSO CONTAIN HIGH PRESSURE ALARMS. THE REASON FOR HIGH PRESSURE ALARMS CAN BE DUE TO A CLOGGED FILTER. HOWEVER WE DID NOT GET ANY INFORMATION THAT IF ANY FILTER IS USED DURING THE EVENT OR NOT. NO PARTS REPLACED IN THE SYSTEM AND THE VENTILATOR PASSED PRE-USE CHECK AND DID NOT INDICATE ANY MALFUNCTION ACCORDING TO OUR FSE. THE LOGS DO NOT CONTAIN ERROR RELATED TO THE ISSUE, THEREFORE, WE CANNOT DETERMINE THE CAUSE FOR HIGH PRESSURE ALARMS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE VENTILATOR ALARMED FOR HIGH PRESSURE. THERE WAS NO PATIENT INVOLVEMENT. (B)(4).

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127424 SERVO-U VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1