BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BABYLOG VN600

    MDR report key: 19330508 · Received May 16, 2024

    Report

    Report Number
    9611500-2024-00214
    Event Type
    Injury
    Date Received
    May 16, 2024
    Date of Event
    April 18, 2024
    Report Date
    June 14, 2024
    Manufacturer
    DRÄGERWERK AG & CO. KGAA
    Product Code
    QOV
    UDI-DI
    04048675551713
    PMA / PMN Number
    EUA201036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION HAS JUST STARTED; RESULTS WILL BE PROVIDED IN A FOLLOW-UP REPORT. H3 OTHER TEXT : ON-GOING.

    Additional Manufacturer Narrative · 0

    THE AFFECTED DEVICE WAS EXAMINED ONSITE BY THE DRÄGER SERVICE. THE LOG FILE OF THE DEVICE WAS MADE AVAILABLE FOR FURTHER INVESTIGATION. BASED ON THE ANALYSIS OF THE LOG FILE THE REPORTED EVENT COULD BE VERIFIED. THE LOG FILE ANALYSIS REVEALED THAT THE DEVICE POSTED SEVERAL VENTILATION RELATED ALARM MESSAGES, E.G. "RESPIRATORY RATE HIGH". ROOT CAUSE WAS AN ISSUE WITH THE BREATHING CIRCUIT LIKE FLUID IN BREATHING CIRCUIT. THE ANALYSIS FOUND NO INDICATION FOR A DEVICE MALFUNCTION. IN CASE OF A DETECTED DEVIATION OF VENTILATION RELATED MEASUREMENT VALUES E.G. AIRWAY PRESSURE OR RESPIRATORY RATE THE DEVICE WOULD POST ACCOMPANYING ALARM MESSAGES IN ACCORDANCE TO SET ALARM LIMITS TO INFORM THE USER ABOUT THE PROBLEM. THE DEVICE REACTED AS SPECIFIED. THE NUMBER OF SIMILAR CASES, RELATED TO THE SAME ROOT CAUSE, IS WITHIN THE EXPECTED RANGE OF THE RESPECTIVE RISK ASSESSMENT AND THUS ACCEPTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PRETERM, SEDATED BABY WAS CONNECTED TO THE VENTILATOR. AT AROUND 03:30 P.M. THE "BABY SUDDENLY DETERIORATED WITH POOR PERFUSION AND DESATURATION. BABY WAS CHECKED AND A CHEST X-RAY WAS DONE, BUT NO PNEUMOTHORAX WAS NOTED. THE VENTILATOR WAS SHOWING A HIGH RESPIRATORY RATE (UP TO 114) AND A PRESSURE AND FLOW RATE CURVE WITH MARKEDLY CHANGED TO FASCICULATION. THE BABY WAS DISCONNECTED FROM THE VENTILATOR AND THE TEST LUNG WAS CONNECTED. THE SAME PROBLEM CONTINUED EVENT WITH THE TEST LUNG.".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PRETERM, SEDATED BABY WAS CONNECTED TO THE VENTILATOR. AT AROUND 03:30 P.M. THE "BABY SUDDENLY DETERIORATED WITH POOR PERFUSION AND DESATURATION. BABY WAS CHECKED AND A CHEST X-RAY WAS DONE, BUT NO PNEUMOTHORAX WAS NOTED. THE VENTILATOR WAS SHOWING A HIGH RESPIRATORY RATE (UP TO 114) AND A PRESSURE AND FLOW RATE CURVE WITH MARKEDLY CHANGED TO FASCICULATION. THE BABY WAS DISCONNECTED FROM THE VENTILATOR AND THE TEST LUNG WAS CONNECTED. THE SAME PROBLEM CONTINUED EVENT WITH THE TEST LUNG."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633610 BABYLOG VN600 ANAESTHESIA AND PULMONARY VENTILATION SUPPORT INSTRUMENT QOV DRÄGERWERK AG & CO. KGAA NA NA 04048675551713

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention