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	Electrical /Electronic Property Problem (1198); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2025
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 approximately 30 to 45 minutes after initiation of support, a temporary malfunction of the extracorporeal membrane oxygenation (ecmo) system occurred.The event was characterized by a brief shutdown of the console display and a short interruption of blood flow.Following spontaneous recovery of the console, an alarm indicating loss of communication between the sensor box and the console was displayed.Immediate clinical actions were taken, including clamping of the cannulas and restoration of blood flow.The system resumed normal operation after a short interruption and continued to function without recurrence for the remainder of the ecmo support.There was no patient serious injury.The complaint sample was 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: 24574362
• Report Number: 3012172416-2026-00020
• Device Sequence Number: 10326333
• Product Code: QJZ
• UDI-Device Identifier: 04057224902043
• UDI-Public: 04057224902043
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• 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): 06/10/2026

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 Catalogue Number: F30000162
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2026
• Supplement Date Received by Manufacturer: 06/03/2026
• Initial Report FDA Received Date: 03/11/2026
• Supplement Report FDA Received Date: 06/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/31/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: XLUNG KIT 230.
• Patient Sex: Male