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

Model Number	5704811
Medical Device Problem Codes	No Device Output (1435); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2026
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 a critically ill patients respiratory condition had deteriorated.Manual ventilation and later the intubation improved the spo2 and etco2 levels.During the following oxylog ventilation, no rise and fall of chest seen and no air entry to either lung on auscultation.Therefore manual ventilation was then continued until the paramedic arrived.Manually ventilated 3hrs.No serious injury.

• 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: 25134652
• Report Number: 9611500-2026-00198
• Device Sequence Number: 9453770
• Product Code: CBK
• UDI-Device Identifier: 04048675249221
• UDI-Public: (01)04048675249221(11)151015(93)5704811-22
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2026

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: 5704811
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/15/2026
• Supplement Date Received by Manufacturer: 06/11/2026
• Initial Report FDA Received Date: 05/11/2026
• Supplement Report FDA Received Date: 06/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2015
• 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