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

Model Number	5704811
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The received user facility report was the only source of information - draeger attempted to obtain further information, but this was not successful, a case-specific evaluation is thus not possible and no root cause can be determined.There was no involvement or service contract with draeger - the manufacturer is not able to draw a conclusion about the root cause of the reported malfunction but it can be emphasized that the situation was alarmed and displayed by the device.The user of this emergency/transport ventilator is always present and can change to an alternative ventilation method that according to the ifu has always to be kept as a back-up immediately.
Event or Problem Description
It was reported that during a patient transfer, the transport ventilator displayed a device malfunction and became inoperable.No injury or health consequences for the patient were 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): BAY STATE ANESTHESIA; 30 willow street; north andover MA 01845
• Manufacturer Contact: 30 willow street; north andover, MA 01845 ; 4518822868
• MDR Report Key: 25530250
• Report Number: 9611500-2026-00299
• Device Sequence Number: 15861548
• Product Code: CBK
• UDI-Device Identifier: 04048675249221
• UDI-Public: (01)04048675249221(11)230113(93)5704811-24
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K103625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/17/2026

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/01/2026
• Initial Report FDA Received Date: 06/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/13/2023
• 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