BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAVINA 300

    MDR report key: 22306208 · Received June 23, 2025

    Report

    Report Number
    9611500-2025-00323
    Event Type
    Malfunction
    Date Received
    June 23, 2025
    Date of Event
    June 11, 2025
    Report Date
    June 23, 2025
    Manufacturer
    DRÄGERWERK AG & CO. KGAA
    Product Code
    CBK
    UDI-DI
    04048675411628
    PMA / PMN Number
    K003068
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE UFR WAS THE ONLY SOURCE OF INFORMATION; THE HOSPITAL DID NOT INVOLVE THE LOCAL DRÄGER S&S ORGANIZATION INTO ANY FOLLOW-UP MEASURES AND DID NOT PROVIDE ADDITIONAL DETAILS UPON REQUEST. A CASE-SPECIFIC EVALUATION IS NOT POSSIBLE. THE FOLLOWING CAN BE DERIVED FROM THE UFR: THE DEVICE REPORTEDLY PERFORMED A REBOOT. THIS IS THE SPECIFIED BEHAVIOR TO OVERCOME INTERRUPTS IN THE PROCESSING OF SW ROUTINES THAT CANNOT BE RECTIFIED BY OTHER MEANS. THE DEVICE WILL BRIEFLY POWER OFF AND BACK ON AND CONTINUE VENTILATION WITH THE LATEST SETTINGS IF THE REBOOT REMEDIES THE ERROR CONDITION. A TYPICAL REBOOT LASTS APPROX. 12 SECONDS; THE DEVICE OPENS THE AIRWAY SYSTEM TO AMBIENT DURING THIS TIME TO ALLOW SPONTANEOUS BREATHING. THE EXACT ROOT CAUSE CANNOT BE DERIVED FROM THE INFORMATION SUPPLIED WITH THE UFR. HOWEVER, BASED ON EXPERIENCE, THE MOST LIKELY EXPLANATION WOULD BE THAT THE DEVICE WAS PUT INTO OPERATION WITH A WORN INTERNAL BATTERY. THE INTERNAL BATTERY SERVES AS AN IMPORTANT FAIL-SAFE MECHANISM AND WILL THUS BE TESTED IN REGULAR INTERVALS BY THE SOFTWARE TO CALCULATE THE RUNTIME FORECAST. IF THE BATTERY IS WORN TO A CERTAIN DEGREE THAT THE VOLTAGE DROPS SIGNIFICANTLY DURING THIS TEST, THIS MAY TRIGGER A REBOOT. IF THE POSTULATION IS CORRECT, THE REPORTED EVENT MUST BE ATTRIBUTED TO LACK OF PREVENTIVE MAINTENANCE AND TO FAILURE TO FOLLOW THE INSTRUCTIONS OF THE MANUFACTURER; THE IFU EMPHAZISES THAT AVAILABILITY OF THE INTERNAL BATTERY SHALL BE CHECKED PRIOR TO EACH NEW VENTILATION EPISODE. OTHER EXPLANATIONS MAY APPLY AS WELL; A FURTHER DIFFERENTIATION IS NOT POSSIBLE. IT IS RECOMMENDED TO THE HOSPITAL TO HAVE THE DEVICE CHECKED BY TRAINED SERVICE PERSONNEL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE PERFORMED A REBOOT APPROX. 2 HOURS AFTER START OF THE VENTILATION EPISODE. THE USERS REPORTEDLY REPLACED THE DEVICE IN A CONTROLLED MANEUVER IN ABUNDANCE OF CAUTION; HEALTH CONSEQUENCES FOR THE PATIENT DID NOT OCCUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    732738 SAVINA 300 VENTILATOR, INTENSIVE CARE CBK DRÄGERWERK AG & CO. KGAA 8417801 04048675411628

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown NA.