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

Model Number	NOVALUNG CONSOLE (LINUX BOARD)
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2025
Type of Reportable Event	Malfunction
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 that on (b)(6) 2025 at approximately 7:15 pm (local), the xenios console (s/n: (b)(6), which had been on standby and primed since on (b)(6) 2025 at 2800 rpm and 2.0 l/min flow, unexpectedly switched to emergency mode and two critical alarms were triggered: # 403 - technical failure: operator panel and #10e - pump drive in emergency mode.This was accompanied by continuous audible warning.Upon inspection, the touch panel was responsive, but the rotary knob and switch keys were nonfunctional.After removing and inserting the console´s batteries, the system restarted and functioned normally.There was no patient involvement.The complaint sample was not available for product evaluation.
Additional Manufacturer Narrative
Additional information: h6 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 showed no repair activities.The console was inspected onsite, and the reported failure could not be reproduced.No defect was found.A software update to the latest version (3.2.4) has been performed, and the device is ready for use again.
Event or Problem Description
A user facility reported that on (b)(6) 2025 at approximately 7:15 pm (local), the xenios console (s/n (b)(6)), which had been on standby and primed since (b)(6) 2025 at 2800 rpm and 2.0 l/min flow, unexpectedly switched to emergency mode and two critical alarms were triggered: # 403 - technical failure: operator panel and #10e - pump drive in emergency mode.This was accompanied by continuous audible warning.Upon inspection, the touch panel was responsive, but the rotary knob and switch keys were nonfunctional.After removing and inserting the console´s batteries, the system restarted and functioned normally.There was no patient involvement.The complaint sample was not available for product evaluation.

• 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: 22838530
• Report Number: 3012172416-2025-00082
• Device Sequence Number: 21184684
• 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): 10/24/2025

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: NOVALUNG CONSOLE (LINUX BOARD)
• 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: 08/02/2025
• Supplement Date Received by Manufacturer: 10/10/2025
• Initial Report FDA Received Date: 08/19/2025
• Supplement Report FDA Received Date: 10/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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