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

Model Number	5704831
Medical Device Problem Codes	Use of Device Problem (1670); Failure to Deliver (2338)
Health Effect - Clinical Code	Low Blood Pressure/ Hypotension (1914)
Date of Event	03/06/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported in the user facility report that a trauma patient came to the emergency room in poor condition.The patient had to be urgently intubated.Blood pressure was good.The airway was secured without any problems.The patient was immediately connected to the oxylog 3000 ventilator.The machine had been assembled in the emergency room.The ventilator was switched on, no information was displayed on the machine's screen, no curves, no volumes.However, you can hear how the machine is pushing air in at the specified frequency.Soon the machine gives an alarm of apparently high pressure.At first, it seems that the patient is ventilated normally.However, the patient's blood pressure quickly collapses.It is noticed that the ventilator is not really working normally, air is going in, but not out.Air is being blocked in the lungs, causing a life-threatening increase in intrathoracic pressure.This causes a decrease in venous return and a sharp drop in blood pressure.The situation is noticed, and the patient is removed from the machine.The blood pressure soon rises to normal, and no further patient injury was reported.
Additional Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.
Event or Problem Description
It was reported in the user facility report that a trauma patient came to the emergency room in poor condition.The patient had to be urgently intubated.Blood pressure was good.The airway was secured without any problems.The patient was immediately connected to the oxylog 3000 ventilator.The machine had been assembled in the emergency room.The ventilator was switched on, no information was displayed on the machine's screen, no curves, no volumes.However, you can hear how the machine is pushing air in at the specified frequency.Soon the machine gives an alarm of apparently high pressure.At first, it seems that the patient is ventilated normally.However, the patient's blood pressure quickly collapses.It is noticed that the ventilator is not really working normally, air is going in, but not out.Air is being blocked in the lungs, causing a life-threatening increase in intrathoracic pressure.This causes a decrease in venous return and a sharp drop in blood pressure.The situation is noticed, and the patient is removed from the machine.The blood pressure soon rises to normal, and no further patient injury was reported.
Additional Manufacturer Narrative
The device was tested onsite by the technician and the log file was secured for analysis.During a full functional test the device showed no malfunction and worked as specified.Analysis of the log file showed the alarm messages ¿paw low¿ and ¿paw measurement inop¿ on the date of event.However, there is no alarm message regarding high airway pressure contrary to the initial report.The user additionally reported that they did not have time to check the specific alarms and the breathing hoses during the event.Based on the available information there is no indication of a device malfunction that caused the event.The alarm messages indicate problems within the breathing hose system.However, the specific root cause could not be determined.In case of a technical problem the device would alarm visually and acoustically.In this case the ifu describes that the user has to have an alternative independent ventilation device available to be used.

• 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 23542 ; GM 23542
• Manufacturer Contact: moislinger allee 53-55; lübeck 23542 ; 4518822868
• MDR Report Key: 21650415
• Report Number: 9611500-2025-00135
• Device Sequence Number: 21151318
• Product Code: CBK
• UDI-Device Identifier: 04048675249214
• UDI-Public: (01)04048675249214(11)201019(93)5704833-36
• Combination Product (Y/N): N
• 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): 03/20/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 5704831
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/11/2025
• Supplement Date Received by Manufacturer: 04/14/2025
• Initial Report FDA Received Date: 03/20/2025
• Supplement Report FDA Received Date: 05/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/19/2020
• 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