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

Model Number	8417801
Medical Device Problem Codes	Gas Output Problem (1266); Failure to Deliver (2338); No Apparent Adverse Event (3189); Activation Failure (3270)
Health Effect - Clinical Codes	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.
Event or Problem Description
It was reported that the device had to be replaced as it was turning off during patient use.No health consequences for the patient reported.
Additional Manufacturer Narrative
The investigation was performed on the provided information.Other than initially reported, the failure occurred during device check prior to patient use.The ventilation was not active, and no patient was involved.During device check, the device indicated a failed test step for the expiratory valve and the safety valve.The expiratory valve and the flow sensor have been replaced to resolve the failure.According to the instructions for use, a device check must be performed prior to use to ensure operational readiness of the device.In case of a detected deviation e.G., the expiratory valve, the corresponding test step will be displayed as failed to inform the user about the issue.The device behaved as specified.Based on the investigation results this case is assessed to be not reportable anymore as neither a death nor a serious deterioration in the patient's state of health occurred and this is not to be expected in the event of a recurrence.
Event or Problem Description
It was reported that the device had to be replaced as it was turning off during patient use.No health consequences for the patient reported.

• 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: 25027521
• Report Number: 9611500-2026-00181
• Device Sequence Number: 18639816
• Product Code: CBK
• UDI-Device Identifier: 04048675251422
• UDI-Public: (01)04048675251422(11)201021(93)8417800-42
• 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,Followup
• Report Date (Section B): 06/01/2026

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/31/2026
• Supplement Date Received by Manufacturer: 05/06/2026
• Initial Report FDA Received Date: 04/29/2026
• Supplement Report FDA Received Date: 06/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/21/2020
• 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