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

Model Number	5704811
Medical Device Problem Codes	Complete Blockage (1094); Gas Output Problem (1266); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2025
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 patient was being transferred between two areas, when the staff noticed that the patient was no longer ventilating-end tidal co2 was not being recorded.The staff, as a result manually ventilated the patient until the end tidal co2 reappeared-which was straightforward.They rebooted the ventilator and put the patient back on it and successfully transferred the patient.The patient was unharmed.
Event or Problem Description
It was reported that the patient was being transferred between two areas, when the staff noticed that the patient was no longer ventilating-end tidal co2 was not being recorded.The staff, as a result manually ventilated the patient until the end tidal co2 reappeared-which was straightforward.They rebooted the ventilator and put the patient back on it and successfully transferred the patient.The patient was unharmed.
Additional Manufacturer Narrative
The investigation was based on the reported event incl.Photos provided and log of the affected oxylog 3000plus device.Furthermore, the device was examined onsite by dräger service technician.During onsite investigation no actual faults with the device¿s ability to ventilate could be detected but damage to both the front and rear housing were visible.According to the log analysis, there were hints of a stenosis or a blockage within the breathing hose system.A brief switch to spn-cpap mode may have occurred to relieve the stenosis, which could explain the sudden stop in ventilation¿particularly if the patient was not breathing spontaneously.In the case of a stenosis, the device would trigger a '!!! paw high' or ' continuous high pressure' alarm or similar.However, this cannot be evaluated because earlier parts of the logs been overwritten.Therefore, it is not possible to determine a specific root cause for the reported event.No patient health consequences have been reported.In case of a technical problem (e.G."device stopped ventilating") the device alarms visually and acoustically.Potentially the ventilation is not sufficient anymore.In this case, an alternative independent ventilation device has to be used instantly, as described in the ifu.The device was inspected in accordance with manufacturer specs and passed all checks.External damages have been repaired.The results of the investigation did not reveal any new risks which are not covered by the product risk management file.

• 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 23542 ; GM 23542
• Manufacturer Contact: moislinger allee 53-55; lübeck 23542 ; 4518822868
• MDR Report Key: 22131448
• Report Number: 9611500-2025-00283
• Device Sequence Number: 8371519
• Product Code: CBK
• UDI-Device Identifier: 04048675249221
• UDI-Public: (01)04048675249221(11)200706(93)5704811-22
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 07/22/2025

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: 5704811
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/20/2025
• Supplement Date Received by Manufacturer: 07/16/2025
• Initial Report FDA Received Date: 06/03/2025
• Supplement Report FDA Received Date: 07/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/06/2020
• 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