BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLAN A300

    MDR report key: 21975658 · Received May 7, 2025

    Report

    Report Number
    9611500-2025-00230
    Event Type
    Malfunction
    Date Received
    May 7, 2025
    Date of Event
    April 16, 2025
    Report Date
    August 15, 2025
    Manufacturer
    DRÄGERWERK AG & CO. KGAA
    Product Code
    BSZ
    UDI-DI
    04048675556343
    PMA / PMN Number
    K230931
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION WAS JUST STARTED. THE RESULT WILL BE FORWARDED IN A FOLLOW-UP REPORT.

    Additional Manufacturer Narrative · 0

    FOR THE INVESTIGATION THE LOGFILE WAS ANALYSED, THE DESCRIBED BEHAVIOUR COULD BE CONFIRMED. ROOT CAUSE WAS THAT THE VALUE OF THE MEASURED AMBIENT PRESSURE DROPPED DURING AUTOMATIC VENTILATION ON THE DATE OF EVENT. AS THE ATLAN USES THE AMBIENT PRESSURE FOR THE CORRECT FRESH GAS VOLUME CALCULATION AND O2 CONCENTRATION CALCULATION, THE DEVICE ALARMED IN THE CONSEQUENCE FOR ¿FRESH-GAS FLOW INACCURATE¿ AND ¿O2 CONCENTRATION IMPLAUSIBLY HIGH¿, AMONGST OTHERS, AS SPECIFIED. AS REPORTED, CONTROLLED VENTILATION IN AUTOMATIC AND MANUAL VENTILATION WAS NOT POSSIBLE ANYMORE. THE VENTILATOR FINALLY ALARMED OPTICALLY AND ACOUSTICALLY FOR ¿VENTILATOR FAILURE¿ WITH THE HIGHEST ALARM PRIORITY. THE ATLAN IS EQUIPPED WITH AN INTEGRATED PRESSURE, VOLUME AND GAS MONITORING (OPTIONALLY INTEGRATED). IN THE EVENT OF AN UNSTEADY FRESH GAS AND AIR FLOW, ALARMS ARE SIGNALED OPTICALLY AND ACOUSTICALLY, DEPENDING ON THE ALARM LIMITS ADJUSTED BY THE USER. AS STATED IN THE IFU, THE BACKUP MANUAL MODE IS AVAILABLE IN THIS STATE. USING THE BACKUP VENTILATION, THE USER CAN MANUALLY VENTILATE THE PATIENT (INCL. AGENT DOSAGE). THE RESPECTIVE O2 SENSOR AND PRESSURE SENSOR WERE AVAILABLE FOR THE INVESTIGATION. AS THEY WERE FOUND TO BE WITHIN SPECIFICATION, IT WAS NOT POSSIBLE TO DETERMINE THE EXACT ROOT CAUSE. THIS CASE IS RATED AS A SINGLE EVENT. RISK MANAGEMENT WAS REVIEWED AND WAS FOUND TO BE ADEQUATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A VENTILATOR FAILURE OCCURRED DURING VENTILATION. A MESSAGE ¿SWITCH TO THE MAN/SPON VENTILATION MODE¿ APPEARED ON THE MONITOR. HOWEVER, THE SET FRESH GAS AND AIR DID NOT FLOW STEADILY AS SET, AS WITH A JET VENTILATOR, AND PROPER MANUAL VENTILATION WAS NOT POSSIBLE. THEREFORE, O2 WAS ADMINISTERED WITH AN AUXILIARY O2 FLOWMETER AND VENTILATION WAS PERFORMED WITH A JACKSON RELEASE. NO INJURY WAS REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A VENTILATOR FAILURE OCCURRED DURING VENTILATION. A MESSAGE ¿SWITCH TO THE MAN/SPON VENTILATION MODE¿ APPEARED ON THE MONITOR. HOWEVER, THE SET FRESH GAS AND AIR DID NOT FLOW STEADILY AS SET, AS WITH A JET VENTILATOR, AND PROPER MANUAL VENTILATION WAS NOT POSSIBLE. THEREFORE, O2 WAS ADMINISTERED WITH AN AUXILIARY O2 FLOWMETER AND VENTILATION WAS PERFORMED WITH A JACKSON RELEASE. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469070 ATLAN A300 ANESTHESIA UNITS BSZ DRÄGERWERK AG & CO. KGAA 8621300 04048675556343

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown NA.| NA.