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

Model Number	8414000
Medical Device Problem Codes	Gas Output Problem (1266); Failure to Run on Battery (1466); Decrease in Pressure (1490)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	06/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Dräger has received a ufr in which it was reported that the device posted an alarm approx.1 minute after start of the particular ventilation episode and that readings/curves disappeared from the device's screen.As per report, the users have thereupon decided to replace the device in a controlled maneuver with no health consequences for the patient.
Additional Manufacturer Narrative
The user facility report was the only source of information; the hospital did not involve the local dräger s&s organization into any follow-up measures, and the contact person named in the ufr was not able to provide additional details.The description of event leaves room for different interpretations but the combination of aspects/observations suggests as the most likely scenario that the device performed a reboot due to a worn internal battery.The internal battery serves as a fail-safe mechanism to cover mains power losses for at least 30 minutes.The device software performs a battery test procedure in the background in regular intervals to calculate the battery status and the runtime forecast.In particular, the device software switches off the mains supply for 500ms to measure the trends for voltage and current in battery operation.With an outdated or depleted battery, the voltage drop may that significant within this short period that running sw processes become interrupted.This will then trigger a reboot of the entire device to set all sw processes back to a controlled state.During a reboot sequence the airway pressure will be released to ambient and, the device posts an alarm to alert the user about the reboot.After a typical period of 12 seconds the reboot will be completed and, the device resumes ventilation with previous settings.As pointed out in the instructions for use, the internal battery shall be regularly checked and replaced every two years at standard operation conditions.Further, the user shall check the availability of the internal battery prior to each use cycle.An overaged or otherwise damaged battery will clearly be identified with these checks and should prevent from putting the device into operation in this state.From the fact that the event nevertheless occurred and - under consideration that the postulation is indeed correct - dräger concludes that lack of maintenance and failure to follow manufacturer¿s instructions were contributing factors in the event.The device was manufactured in 08/2022 and was most likely still equipped at the time of event with the initial battery installed during manufacture.

• Brand Name: SAVINA
• Common Device Name: VENTILATOR, 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 23542 ; GM 23542
• Manufacturer Contact: moislinger allee 53-55; lübeck 23542 ; 4518822868
• MDR Report Key: 22357824
• Report Number: 9611500-2025-00341
• Device Sequence Number: 8621261
• Product Code: CBK
• UDI-Device Identifier: 04048675407881
• UDI-Public: (01)04048675407881
• Combination Product (Y/N): N
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/30/2025

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: 8414000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/20/2025
• Initial Report FDA Received Date: 06/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/29/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NA.
• Patient Sex: Unknown