BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 8394510 · Received March 6, 2019

    Report

    Report Number
    8010042-2019-00136
    Event Type
    Malfunction
    Date Received
    March 6, 2019
    Date of Event
    January 17, 2019
    Report Date
    June 27, 2019
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K123149
    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). THE VENTILATOR WAS INVESTIGATED ON SITE AND NO COMPONENTS WERE REPLACED. NO NEW EVENTS ON THIS VENTILATOR HAVE BEEN REPORTED UNTIL THIS DATE. EVALUATION OF THE RECEIVED DEVICE LOGS SHOWS MATCHING EVENTS. BETWEEN FEBRUARY 17, AT 19:56 AND JANUARY 17, AT 20:33, THERE ARE SEVERAL INDICATIONS OF THE REPORTED ISSUE WITH NOISE AND INTERFERENCE ON THE EXPIRATORY FLOW WAVEFORM. A PRE-USE CHECK WAS CONFIRMED TO BE SUCCESSFUL PRIOR TO THIS VENTILATION PERIOD. AS NO GOODS WERE RETURNED FOR INVESTIGATION, THE CAUSE OF THE REPORTED FAILURE COULD NOT BE DETERMINED.

    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-2019-00355. MANUFACTURER REF. #: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PATIENT TREATMENT, THE VENTILATOR GENERATED NOISE AND INTERFERENCE WAS NOTED ON THE EXPIRATORY FLOW WAVEFORM ON THE SCREEN. THERE WAS NO PATIENT HARM. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186800 SERVO-I VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1