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

Model Number	5704833
Medical Device Problem Code	Medical Gas Supply Problem (2985)
Health Effect - Clinical Codes	Bradycardia (1751); Low Oxygen Saturation (2477)
Date of Event	05/14/2026
Type of Reportable Event	Death
Event or Problem Description
It was reported that the patient was connected to the device coupled to an o2 cylinder with digital display.The digital display of the o2 cylinder was found to be off and the o2 cylinder was exchanged.After a few minutes the patient was identified as having bradycardia and low oxygen saturation.It was found that the exchanged o2 cylinder was empty.The previous o2 cylinder was connected and was functioning normally.The patient required cpr and passed away.
Additional Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.

• 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: 25388392
• Report Number: 9611500-2026-00271
• Device Sequence Number: 10718171
• Product Code: CBK
• UDI-Device Identifier: 04048675249214
• UDI-Public: (01)04048675249214(11)181105(93)5704833-45
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 06/04/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 5704833
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/02/2026
• Initial Report FDA Received Date: 06/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/05/2018
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown