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

Model Number	5704833
Medical Device Problem Codes	Gas Output Problem (1266); Failure to Sense (1559); Failure to Deliver (2338)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2025
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 device stopped ventilation and showed a technical fault during use.No patient injury was reported.
Event or Problem Description
It was reported that the device stopped ventilation and showed a technical fault during use.No patient injury was reported.
Additional Manufacturer Narrative
The log file of the affected device was provided for the investigation.The log entries contain no information for the reported date of event, june 10.On june 11 there are multiple failed device tests, multiple error messages "sensor s6 is outside the valid range" between 09:09 and 11:59 (device time) and two error codes "automatic zeroing function is faulty" at 12:02 and 12:03.The error messages indicate a faulty pcb sensor.After replacement of the pcb sensor the device passed a full functional test without deviation.In case of a technical problem (e.G."device failure") the device alarms visually and acoustically.Potentially the ventilation may stop.In this case an alternative independent ventilation device has to be used instantly, as described in the ifu.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.

• 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: 22528548
• Report Number: 9611500-2025-00388
• Device Sequence Number: 15306289
• Product Code: CBK
• UDI-Device Identifier: 04048675249214
• UDI-Public: (01)04048675249214(11)210302(93)5704833-36
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2025

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: 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: 06/18/2025
• Supplement Date Received by Manufacturer: 12/03/2025
• Initial Report FDA Received Date: 07/17/2025
• Supplement Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/02/2021
• 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