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

Model Number	8417801
Medical Device Problem Codes	Gas Output Problem (1266); Decrease in Pressure (1490); Reset Problem (3019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation was based on the reported event and log analysis.Furthermore, a dräger service technician examined it onsite.According to the log analysis, the reported behavior of one warmstart could be confirmed.During onsite analysis, no technical malfunction could be detected.The device alarmed and behaved as specified due to a deviation within the electronic system.Performing a warm start is an established approach to reach a well-defined and stable operation state of the ventilator after unexpected deviation by restarting internal software processes even without or before operator intervention.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 affected device has sw 5.01 according logfile.This is the original delivered software.It is recommended to perform an update to the newest version.Field quality data are monitored and assessed by responsible product quality board.The results of this investigation did not reveal any new risks which are not covered by the product risk management file.
Event or Problem Description
It was reported that on march 22 9:58p, the unit shutdown while in use.No reported patient injury, the patient was manually ventilated and moved to another ventilator.

• 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: 25313939
• Report Number: 9611500-2026-00255
• Device Sequence Number: 10511861
• Product Code: CBK
• UDI-Device Identifier: 04048675411628
• UDI-Public: (01)04048675411628(11)210708(93)8417801-42
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K180779
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 05/28/2026

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: 8417801
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/29/2026
• Initial Report FDA Received Date: 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/08/2021
• 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