BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVITA V600

    MDR report key: 16520191 · Received March 10, 2023

    Report

    Report Number
    9611500-2023-00092
    Event Type
    Injury
    Date Received
    March 10, 2023
    Date of Event
    February 27, 2023
    Report Date
    May 3, 2023
    Manufacturer
    DRÄGERWERK AG & CO. KGAA
    Product Code
    QOV
    UDI-DI
    04048675548744
    PMA / PMN Number
    EUA200143
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE AFFECTED DEVICE WAS TESTED ON SITE BY DRÄGER SERVICE AND THE LOGBOOK WAS AVAILABLE FOR A DETAILED ANALYSIS. DURING THE TEST OF A TEST RUN, NO MALFUNCTION WAS FOUND. THE LOGBOOK ENTRIES SHOW THAT THE PC-BIPAP VENTILATION MODE WAS SELECTED AT 5:17 A.M. ON FEBRUARY 27. SHORTLY THEREAFTER, THE DEVICE ISSUED SEVERAL ALARM MESSAGES REGARDING "MINUTE VOLUME LOW", "TIDAL VOLUME LOW" AND "NO INSPIRATORY FLOW DETECTED". THERE IS NO INDICATION OF A DEVICE MALFUNCTION IN THE LOGBOOK ENTRIES. THE GENERATED ALARMS INDICATE AN OBSTRUCTION IN THE RESPIRATORY SYSTEM. THE SAFETY SOFTWARE CONTINUOUSLY MONITORS THE CORRECT OPERATION OF THE DEVICE. IF AN OBSTRUCTION OCCURS IN THE BREATHING CIRCUIT, TUBE OR MASK, OR IF THE PATIENT BREATHES AGAINST THE VENTILATION STROKES DURING PRESSURE-CONTROLLED VENTILATION, THE DEVICE ISSUES THE ALARM MESSAGE "NO INSPIRATORY FLOW DETECTED" TO INFORM THE USER OF AN EXISTING PROBLEM. THE INSTRUCTIONS FOR USE PROVIDE INFORMATION ON TROUBLESHOOTING. THE NUMBER OF SIMILAR CASES IS WITHIN THE EXPECTED RANGE OF THE RESPECTIVE RISK ASSESSMENT AND THUS ACCEPTED. BASED ON THE INVESTIGATION RESULTS THIS CASE IS NOT CONSIDERED REPORTABLE ANYMORE AS THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY AND WOULD NOT RESULT IN A SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION HAS JUST STARTED; RESULTS WILL BE PROVIDED IN A FOLLOW-UP REPORT. ON-GOING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE ALARMED SEVERAL TIMES WITH THE MESSAGE "NO INSP. FLOW DETECTED" BUT DISPLAYED A PRESSURE CURVE. THE TUBE WAS REMOVED AND NO FLOW WAS DETECTED ON THE TUBE. THE PATIENT WAS RESUSCITATED AND VENTILATED BY HAND. THE PATIENT'S CONDITION THEN STABILIZED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE ALARMED SEVERAL TIMES WITH THE MESSAGE "NO INSP. FLOW DETECTED" BUT DISPLAYED A PRESSURE CURVE. THE TUBE WAS REMOVED AND NO FLOW WAS DETECTED ON THE TUBE. THE PATIENT WAS RESUSCITATED AND VENTILATED BY HAND. THE PATIENT'S CONDITION THEN STABILIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1148789 EVITA V600 VENTILATORS, INTENSIVE CARE QOV DRÄGERWERK AG & CO. KGAA NA NA 04048675548744

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention