MAUDE Adverse Event Report: XENIOS AG NOVALUNG CONSOLE (LINUX BOARD); EXTRACORPOREAL SYSTEM FOR LONG-TERM RESPIRATORY / CARDIOPULMONARY FAILURE

Catalog Number	F30000162
Medical Device Problem Codes	Device Alarm System (1012); Protective Measures Problem (3015); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility reported the following alarms from xenios console sn xen0720 upon starting operation and before patient application: #10e- pump drive in emergency mode, #211- technical failure, flow measurement, #009- tech.The facility was instructed to restart the device which resolved the issue.There was no patient involvement.The console was not available for product evaluation.
Additional Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
Event or Problem Description
A user facility reported the following alarms from xenios console sn (b)(6) upon starting operation and before patient application: #10e: pump drive in emergency mode, #211: technical failure, flow measurement, #009- tech.The facility was instructed to restart the device which resolved the issue.There was no patient involvement.The console was not available for product evaluation.Machine logfiles were received by the product investigation team.
Additional Manufacturer Narrative
Additional information: h4, b5.Plant investigation: non-conformity was not observed during manufacturing process.The review of the repair history in the qtrak complaint amd system of the console xen0720 showed no repair activities.Further inspection by a xenios technician of the console on site revealed no defects, and the failure could not be reproduced.A software update to the latest version (3.2.4) has been performed.The analysis of the log data indicates a delayed start of the operating system which causes alarms codes 10e, 009 and 00b.These alarms disappear once the human-machine-interface (hmi) has started.If this occurs repeatedly, it is advisable to replace the linux board; however, alarm #211 is unrelated.This occurs when the sensor measures a lot of air or there is only air in the tube, or the flow sensor is not mounted on the tube at all, which is likely during preparation if the system.

• Brand Name: NOVALUNG CONSOLE (LINUX BOARD)
• Common Device Name: EXTRACORPOREAL SYSTEM FOR LONG-TERM RESPIRATORY / CARDIOPULMONARY FAILURE
• Manufacturer (Section D): XENIOS AG; director of quality; im zukunftspark 1; heilbronn baden-wurttemberg 74076 ; GM 74076
• Manufacturer (Section G): XENIOS AG; director of quality; im zukunftspark 1; heilbronn baden-wurttemberg 74076 ; GM 74076
• Manufacturer Contact: jessica trujillo ; 920 winter st; waltham, MA 02451 ; 6174175172
• MDR Report Key: 23154023
• Report Number: 3012172416-2025-00098
• Device Sequence Number: 20122140
• Product Code: QJZ
• UDI-Device Identifier: 04057224902043
• UDI-Public: 04057224902043
• Combination Product (Y/N): N
• Initial Reporter Country: KU
• PMA/510(K) Number: K191407
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2025

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 Catalogue Number: F30000162
• Was Device Available for Evaluation?: No
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2025
• Supplement Date Received by Manufacturer: 10/17/2025
• Initial Report FDA Received Date: 09/26/2025
• Supplement Report FDA Received Date: 10/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2020
• 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
• Patient Sex: Unknown