MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA SAVINA 300; VENTILATORS, INTENSIVE CARE

Model Number	8417800
Medical Device Problem Codes	Gas Output Problem (1266); Decrease in Pressure (1490); Data Problem (3196)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2026, during patient use, the device restarted while the ventilation settings were being changed and device failure 16.3010 occurred.No patient health consequences habe been reported.
Additional Manufacturer Narrative
The examination of the log file provided revealed that a medibus communication error was logged before the reported restart was performed.The device alarmed error code 16.3010.This confirmed the reported behavior.The root cause was a disturbed or sometimes disconnected medibus(x) transmission to the external medibus device.Performing a warm restart is an established approach to achieve a well-defined and stable operating state of the ventilator after an unexpected deviation by restarting internal software processes even without or before operator intervention.The device alarmed and behaved as specified.The restart was successful.Savina monitors continuously the state and the function of internal components and software modules.If a deviation or abnormality is detected, an acoustical and optical alarm is generated.The pneumatic system opens which reduces airway pressure to ambient pressure and spontaneous breathing is possible for the patient.This system reset is combined with an audible and visible alarm of high priority.After approximately 12 sec savina continues ventilating the patient with the last settings in case this system reset has solved the original deviation.The external monitor system is recommended to secure a stable medibus(x) communication.The risk assessment concerning the reported event does not reveal any new or additional risk with respect to the known risks at the time of product design, during product improvement process and risks to be expected in the frame of the intended purpose; consequently, this is considered within the device safety concept.

• Brand Name: SAVINA 300
• Common Device Name: VENTILATORS, INTENSIVE CARE
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck ; GM
• Manufacturer (Section G): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23558 ; GM 23558
• Manufacturer Contact: moislinger allee 53-55; lübeck 23558 ; 4518822868
• MDR Report Key: 25199980
• Report Number: 9611500-2026-00232
• Device Sequence Number: 8963445
• Product Code: CBK
• UDI-Device Identifier: 04048675251422
• UDI-Public: (01)04048675251422(11)180412(93)8417800-35
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K121886
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/18/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 8417800
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/20/2026
• Initial Report FDA Received Date: 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/12/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown