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 Run on Battery (1466); Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
After the event there was a request to a draeger field service technician but not yet ordered by the hospital.A part of the device log (screenshot of the service screen) was provided - the analysis by manufacturer's device expert revealed that several different battery related error codes (leading to alarm and failure messages) were recorded over a period of time.With foregoing wear status of the battery, the ventilator finished the (daily) pre-use check in non-functional state; the device can only be put into use then when the user acknowledges the restriction.So, it must be concluded that the battery related device tests have been ignored by the user.Furthermore, it must be clearly emphasized that the instructions for use (ifu) of the device clearly indicates that batteries are subject to maintenance and must be exchanged according to the defined intervals requested in the ifu.The affected device was manufactured in march 2020 =; its status or history of maintenance is unknown to the manufacturer.Finally, the manufacturer concludes that the reported problem was primary related to use error(s) - fail of maintenance, i.E.Exchange of wear and tear parts and further use against failed device checks over a period of time.The actual status of repair and further use/service of the device is unknown to the manufacturer.
Event or Problem Description
It was reported that during use on a patient the ventilator screen suddenly blacked out and the device automatically rebooted twice.The patient was then connected to a spare device - no injury or serious impairment of patients state of health was 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: 24687413
• Report Number: 9611500-2026-00128
• Device Sequence Number: 9977241
• Product Code: CBK
• UDI-Device Identifier: 04048675251422
• UDI-Public: (01)04048675251422(11)200313(17)230201(93)8417800-41
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 03/25/2026

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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/05/2026
• Initial Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/13/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NA.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown