MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA OXYLOG 3000PLUS; VENTILATORS, TRANSPORT

Model Number	5704833
Medical Device Problem Codes	Gas Output Problem (1266); Decrease in Pressure (1490); Reset Problem (3019); Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported ventilator powered down during transport.The user observed no error code and only saw a black screen.The issue occurred when the patient was transferring onto the ventilator in the intensive care unit.No patient injury was reported.
Additional Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.
Additional Manufacturer Narrative
The affected device was tested by draeger service and the log file was provided for further analysis.During the device test the technician found error log messages indicating a faulty control pcb.After replacement the device passed a full functional test according to manufacturer specification.Detailed analysis of the log entries showed that the last successful device check was performed on 15 november 2025 at 14:11.On the date of event 16 november 2025 no device check was performed, and the ventilation was started at 14:04.At 14:14:05 the device a deviation regarding the internal voltage, alarmed ¿device failure¿ and logged the error message ¿bias voltage vvent is outside the range¿.As a result, the device performed a restart of the system in an attempt to solve the deviation.The error message was repeated 40 seconds later at 14:14:45 and within the same minute the device was switched off by the user at 14:14:59.A faulty control pcb was identified as the root cause for the deviation in this case and the replacement solved the issue.In case of a technical problem the device alarms visually and acoustically.The device performed a warmstart as the specified reaction the detected deviation.During a warmstart the ventilation stops.In this case an alternative independent ventilation device has to be used immediately, as described in the ifu.The number of similar cases is within the expected range of the respective risk assessment and thus accepted.
Event or Problem Description
It was reported ventilator powered down during transport.The user observed no error code and only saw a black screen.The issue occurred when the patient was transferring onto the ventilator in the intensive care unit.No patient injury was reported.

• Brand Name: OXYLOG 3000PLUS
• Common Device Name: VENTILATORS, TRANSPORT
• 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: 24065393
• Report Number: 9611500-2026-00010
• Device Sequence Number: 18738473
• Product Code: CBK
• UDI-Device Identifier: 04048675249214
• UDI-Public: (01)04048675249214(11)180413(93)5704833-28
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K103625
• 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,Followup
• Report Date (Section B): 03/06/2026

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: 5704833
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/15/2025
• Supplement Date Received by Manufacturer: 02/09/2026
• Initial Report FDA Received Date: 01/14/2026
• Supplement Report FDA Received Date: 03/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/13/2018
• 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.; NA.
• Patient Sex: Unknown