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	10/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device shut down and alarmed device failure while on a patient.No patient injury was reported.
Additional Manufacturer Narrative
The affected device was analyzed on-site by dräger service and the log file was secured for a detailed investigation.Based on the log entries it could be confirmed that the device detected an internal deviation and performed a single restart.Based on the log entries the root cause for the event was determined a disruption in the program run of the software as a single event.The deviation was solved after the restart of the device.A deviation in the electronic system that cannot be rectified by software routines will trigger a restart of the entire system.During the restart sequence which usually does not take longer than 12 seconds the device opens the pneumatic system to ambient to enable spontaneous breathing of the patient.The user will be alerted by means of a corresponding high-priority alarm.After completion of the restart the ventilation will be continued with the last valid settings.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.

• 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: 23754526
• Report Number: 9611500-2025-00674
• Device Sequence Number: 5904766
• Product Code: CBK
• UDI-Device Identifier: 04048675411628
• UDI-Public: (01)04048675411628(11)221222(93)8417801-43
• 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): 12/09/2025

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: 11/18/2025
• Initial Report FDA Received Date: 12/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/22/2022
• 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