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	Circuit Failure (1089); Electrical /Electronic Property Problem (1198); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2025
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 while novalung console xen0718 was in continuous operation on a patient for the past one month, on (b)(6) 2025 at 23:30 (local), the power supply indication unexpectedly disappeared while the unit was connected to the ceiling pendant, which is powered via a ups.Upon inspection, it was observed that the console fuse had blown.Preliminary assessment indicates a probable failure of the smps module.There was no indication of serious patient injury.The complaint sample was available for product investigation.
Additional Manufacturer Narrative
Additional information: b5, d4, d9, h3, h4, h6 plant investigation: no non-conformity was observed during the manufacturing process, and no other complaints have been reported about this device.The power supply board was received on 7/nov/2025 and was forwarded to the supplier for investigation.A defect in the returned power supply board was confirmed.A definitive cause for the defect could not be determined.It was found that a short circuit had caused damage to a component on the power supply board.This short circuit was more than likely caused by a high voltage spike from the mains.
Event or Problem Description
A user facility reported that while novalung console xen0718 was in continuous operation on a patient for the past one month, on (b)(6) 2025 at 23:30 (local), the power supply indication unexpectedly disappeared while the unit was connected to the ceiling pendant, which is powered via an uninterruptable power supply (ups).Upon inspection, it was observed that the console fuse had blown.Preliminary assessment indicates a probable failure of the smps module.[on local follow-up, it was reported that the power supply failure did not result in suboptimal support at any time.The complaint sample was received by the manufacturer for product investigation.

• 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: 23439829
• Report Number: 3012172416-2025-00105
• Device Sequence Number: 8552729
• 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): 04/21/2026

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: 10/13/2025
• Supplement Date Received by Manufacturer: 04/15/2026
• Initial Report FDA Received Date: 10/31/2025
• Supplement Report FDA Received Date: 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2020
• 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.; XLUNG KIT 230.
• Patient Sex: Unknown