BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-U

    MDR report key: 8695338 · Received June 13, 2019

    Report

    Report Number
    8010042-2019-00396
    Event Type
    Malfunction
    Date Received
    June 13, 2019
    Report Date
    September 24, 2021
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K180098
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    OUR FIELD SERVICE ENGINEER (FSE) INVESTIGATED THE VENTILATOR ON SITE, NO FAULT WAS FOUND AND NO PARTS WERE REPLACED. DEVICE LOGS WERE DOWNLOADED AND SENT FOR EVALUATION. THE VENTILATOR DEVICE WAS UPGRADED TO A NEWER SOFTWARE VERSION, SIMULATED TEST VENTILATION FOR 24 HOURS, AND PRE-USE CHECK WAS PERFORMED WITHOUT FAULTS. THE UNIT WAS RETURNED BACK TO CUSTOMER FOR CLINICAL USE. EVALUATION OF THE RECEIVED DEVICE LOGS SHOWS NO STOP OF VENTILATION AT ANY DATE. THE REVIEW OF THE TECHNICAL LOG DO HOWEVER CONFIRM PANEL RESTARTS. THE REPORTED EVENT WAS FOUND TO BE A USER INTERFACE RESTART. A USER INTERFACE RESTARTS DURING ONGOING VENTILATION WILL NOT AFFECT THE VENTILATION, THE VENTILATION CONTINUES WITHOUT INTERRUPTION. IT WILL NOT BE POSSIBLE TO CHANGE VENTILATION SETTINGS UNTIL THE RESTART IS COMPLETED, WHICH WILL BE VISUALLY APPARENT TO THE USER. THE SOFTWARE HAS BEEN IMPROVED AND AS STATED IN THE SERVICE MANUAL THE LATEST RELEASED SYSTEM SW VERSION IS ALWAYS RECOMMENDED. THE SOFTWARE UPGRADE WAS PERFORMED BY OUR FIELD SERVICE ENGINEER DURING THE INVESTIGATION AT THE HOSPITAL.

    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

    MANUFACTURING REF. #(B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE VENTILATOR STOPPED VENTILATING DURING PATIENT TREATMENT. THERE WAS NO PATIENT HARM. MANUFACTURING REF. #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    489016 SERVO-U VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1