BEUDAMED
    FDA Adverse Event Injury Summary report: N

    E500 VENTILATOR SYSTEM

    MDR report key: 5784386 · Received July 11, 2016

    Report

    Report Number
    2023050-2016-00397
    Event Type
    Injury
    Date Received
    July 11, 2016
    Date of Event
    June 15, 2016
    Report Date
    June 15, 2016
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS, INC
    Product Code
    CBK
    PMA / PMN Number
    K061094
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CS
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SERVICE ENGINEER REPORTED THE CUSTOMER SAID THE EXHALED TIDAL VOLUME WAS HIGH BUT NO ALARM WAS GENERATED. AN EXHALATION FILTER WAS NOT INSTALLED, SO THE EXHALATION FLOW SENSOR MESH GOT DIRTY AND PRODUCED THE DIFFERENCE IN THE TIDAL VOLUME MEASUREMENTS. THE EXHALATION FLOW SENSOR MESH WAS REPLACED AND THE VENTILATOR WORKED PROPERLY.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTION: G5 PMA/510 (K) TO K061094. DEVICE EVALUATION: THE EXHALATION MESH/FILTER WAS RETURNED TO MEDTRONIC¿S FAILURE ANALYSIS LABORATORY. A VISUAL INSPECTION OF THE FILTER WAS PERFORMED AND UNKNOWN PARTICLES WERE FOUND ON THE OUTER EDGE WHERE THE O-RING WAS SEATED. AN INVESTIGATION WAS PERFORMED AND THE REPORTED ISSUE WAS NOT DUPLICATED. NO FAULT WAS FOUND WITH THE RETURNED FILTER. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PATIENT USE A VENTILATOR MEASURED EXHALED TIDAL VOLUME WAS INCORRECT UNDER ACTIVE VENTILATION. THE PATIENT WAS STABLE AND WAS TRANSFERRED TO A DIFFERENT VENTILATOR. THERE WAS NO PATIENT HARM/INJURY REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436600 E500 VENTILATOR SYSTEM CONTINUOUS VENTILATOR CBK NEWPORT MEDICAL INSTRUMENTS, INC E500

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention