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

Model Number	8417800
Medical Device Problem Codes	Gas Output Problem (1266); Failure to Run on Battery (1466); Decrease in Pressure (1490)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The user was seeking dräger's assistance on the phone and provided a screenshot of the error log based on which dräger could establish a general diagnosis.Starting approx.One week before the date of event, and until the day the screenshot was made, the device logged 45 instances of a specific error code that points to a completely worn internal battery.The observed reboots can be explained as follows: the internal battery serves as an important fail-safe mechanism and shall thus be checked regularly; the recommended exchange interval is two years.The supervisor software of the device performs a test in regular intervals during device operation to calculate a reliable runtime forecast for battery operation.For that test, mains voltage input will be shut off for 500 milliseconds - according to the measured trends for current consumption and voltage, the battery status can be determined.However, with a completely worn internal battery the voltage drop may be that significant that sw routines become interrupted and that a reboot is required to set these back to a controlled state.The device was in use for five years at the time of event, it cannot be excluded that it was still equipped at the date of event with the first battery installed during manufacture.It is thus recommended to the hospital to make a quick check of the internal battery according to the pre-use check procedure described in the ifu and to consider further measures based on the result.
Event or Problem Description
It was reported to dräger that the ventilator suddenly performed consecutive reboots during a running ventilation episode and had to be replaced.The event itself and the exchange maneuver were reportedly not resulting in health consequences for the patient.

• 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: 23825705
• Report Number: 9611500-2025-00701
• Device Sequence Number: 17413319
• Product Code: CBK
• UDI-Device Identifier: 04048675251422
• UDI-Public: (01)04048675251422(11)200925(17)230108(93)8417800-42
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K003068
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/17/2025

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: 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: 12/03/2025
• Initial Report FDA Received Date: 12/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2020
• 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