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

Model Number	5704833
Medical Device Problem Codes	Use of Device Problem (1670); Failure to Deliver (2338)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	09/24/2025
Type of Reportable Event	Serious Injury
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 patient required cardiopulmonary resuscitation.The heartbeat was restored, and the patient was connected to the oxylog 3000plus for controlled ventilation.Shortly, after the device issued an alarm to reselect the circuit.Upon inspection, the circuit connection was found to be correct.Subsequently, the device alarmed for device malfunction and ceased operation.The ventilator still did not function after restarting.This caused the patient's heart rate to drop again, necessitating continued external chest compressions, manual ventilation with a simple breathing airbag, and epinephrine for cardiac stimulation.After active resuscitation, the patient regained heartbeat.
Additional Manufacturer Narrative
The affected device was examined onsite by the dräger service and the log file was made available for further investigation.Based on the log file analysis the reported event could not be verified.The log file contains no entries on the reported date of event.Upon request, the date of event was changed to the 20th of august 2025.The log file analysis showed that on that day the device was turned on three times for short period of times.However, there is no indication that the ventilation was started during these periods.The log file revealed an entry indicating a malfunction of the sensor pcb.This malfunction would be raised as technical failure by the device.However, the failure occurred while the device was being manually turned off by the user.The sensor pcb was replaced by the dräger service.The device was tested and confirmed to be operating as per manufacturer´s specification.In case of a technical problem the device alarms visually and acoustically.Potentially the ventilation may stop.In the event of a complete loss of ventilator function the emergency air valve opens so that the patient can breathe spontaneously.In this case an alternative independent ventilation device has to be used instantly, as described in the instruction for use.The results of the investigation did not reveal any new risks which are not covered by the product risk management file.
Event or Problem Description
It was reported that the patient required cardiopulmonary resuscitation.The heartbeat was restored, and the patient was connected to the oxylog 3000plus for controlled ventilation.Shortly, after the device issued an alarm to reselect the circuit.Upon inspection, the circuit connection was found to be correct.Subsequently, the device alarmed for device malfunction and ceased operation.The ventilator still did not function after restarting.This caused the patient's heart rate to drop again, necessitating continued external chest compressions, manual ventilation with a simple breathing airbag, and epinephrine for cardiac stimulation.After active resuscitation, the patient regained heartbeat.

• 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: 23252772
• Report Number: 9611500-2025-00570
• Device Sequence Number: 16057080
• Product Code: CBK
• UDI-Device Identifier: 04048675249214
• UDI-Public: (01)04048675249214(11)221102(93)5704833-40
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K103625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 01/12/2026

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/30/2025
• Supplement Date Received by Manufacturer: 12/22/2025
• Initial Report FDA Received Date: 10/09/2025
• Supplement Report FDA Received Date: 01/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/02/2022
• 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: Life Threatening
• Patient Sex: Unknown