BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLAN A350

    MDR report key: 22140794 · Received June 4, 2025

    Report

    Report Number
    9611500-2025-00286
    Event Type
    Malfunction
    Date Received
    June 4, 2025
    Date of Event
    May 21, 2025
    Report Date
    June 4, 2025
    Manufacturer
    DRÄGERWERK AG & CO. KGAA
    Product Code
    BSZ
    UDI-DI
    04048675556176
    PMA / PMN Number
    K230931
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    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. IT WAS FOUND THAT THE SYSTEM TEST WAS COMPLETED SUCCESSFULLY BEFORE AND AFTER THE EVENT. THE DEVICE DETECTED DURING OPERATION IMPLAUSIBLE VALUES WHEN COMPARING THE SIGNALS FOR INSPIRATORY AND EXPIRATORY PRESSURE, WHILE IT CAN BE EXCLUDED THAT THIS WAS DUE TO DEFECTIVE SENSORS. THE DIFFERENCE BETWEEN THE INSPIRATION PRESSURE IS MORE THAN THREE TIMES AS LARGE AS THE PRESSURE IN THE EXPIRATION. THE DEVICE POSTED THE CORRESPONDING "AIRWAY PRESSURE HIGH" ALARMS. IN THE CONSEQUENCE THE DEVICE SWITCHED OFF THE AUTOMATIC VENTILATOR FOR SAFETY MEASURES WHICH WAS ACCOMPANIED BY THE CORRESPONDING ¿VENTILATOR FAILURE¿ ALARM. MANUAL VENTILATION REMAINED POSSIBLE. POSSIBLE REASON FOR SUCH AN IMPLAUSIBLE PRESSURE IS A SPORADIC HIGH RESISTANCE IN THE HOSE SYSTEM DUE TO SQEEZED HOSES, PATIENT ACTIVITY OR RESPOSITIONING THE PATIENT. HOWEVER IT WAS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE MORE PRECISELY. 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 AT AROUND 9.38 P.M., THE ANAESTHESIA MACHINE FAILED DURING AN EMERGENCY PROCEDURE WITH HEART LUNG MACHINE INVOLVEMENT IN HCH OPERATING ROOM 2. "VENTILATOR FAILURE" ... CHANGEOVER OF THE ANESTHESIA MACHINE TO MANUEL MODE WITHOUT PROBLEMS AND SUBSEQUENT START-UP OF ANOTHER VENTILATOR IN ORDER TO CONTINUE MECHANICAL VENTILATION. NO INJURY REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AT AROUND 9.38 P.M., THE ANAESTHESIA MACHINE FAILED DURING AN EMERGENCY PROCEDURE WITH HEART LUNG MACHINE INVOLVEMENT IN HCH OPERATING ROOM 2. "VENTILATOR FAILURE" ... CHANGEOVER OF THE ANESTHESIA MACHINE TO MANUEL MODE WITHOUT PROBLEMS AND SUBSEQUENT START-UP OF ANOTHER VENTILATOR IN ORDER TO CONTINUE MECHANICAL VENTILATION. NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    717960 ATLAN A350 ANESTHESIA UNITS BSZ DRÄGERWERK AG & CO. KGAA 8621500 04048675556176

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown