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

Model Number	5704811
Medical Device Problem Codes	Failure to Charge (1085); Output Problem (3005); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported a battery issue and the ventilator stopped whilst in use.No patient health consequences have been reported.
Additional Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.
Additional Manufacturer Narrative
The oxylog 3000plus device was analyzed via provided information incl.The secured log files.Upon request we got the information from the customer, that the reported event did not occur during use on a patient, it occurred during the self-test.According to the logfile analysis this could be confirmed.There was no indication for a stop of ventilation due to a depleted or defective battery.The affected device alarmed and behaved as specified indicating a charging problem and was then shut down by user.Afterwards the battery function wad tested without patient involvement.In case that the alarm "no int.Battery charging" is displayed, the ifu requires the internal battery to be removed and reinserted or replaced as a remedy for this error message.The "charge internal battery" alarm and the "internal battery discharged" alarm are correctly displayed and warn the user about a low battery level.In some cases, charging of the internal battery was not finally completed because a full state of charge was not recognized in time.It is therefore recommended that if a red charging led appears, the battery should be removed and plugged in again to interrupt the timeout and restart the charging cycle.The dräger service technician onsite has already replaced the charger pcb and the battery.The device was tested afterwards according to manufacturer specs and passed successfully.The risk arising from the battery fault indication situation is covered by the risk management report, no previously undetected risks have arisen.No change of risk management report necessary.Based on the investigation results this case is considered not to be reportable according to the medical device regulation (mdr (b)(4) as neither death nor a serious injury were caused nor would it be expected to occur in case of recurrence.
Event or Problem Description
The customer reported a battery issue and the ventilator stopped whilst in use.No patient health consequences have been 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): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23558 ; GM 23558
• Manufacturer Contact: moislinger allee 53-55; lübeck 23558 ; 4518822868
• MDR Report Key: 24312659
• Report Number: 9611500-2026-00051
• Device Sequence Number: 5676651
• Product Code: CBK
• UDI-Device Identifier: 04048675249221
• UDI-Public: (01)04048675249221(11)230207(93)5704811-24
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2026

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): Initial
• Initial Date Received by Manufacturer: 01/28/2026
• Supplement Date Received by Manufacturer: 03/17/2026
• Initial Report FDA Received Date: 02/11/2026
• Supplement Report FDA Received Date: 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2023
• 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
• Patient Sex: Unknown