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); Loss of Power (1475); Electrical Power Problem (2925)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2025
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 the novalung console was in use on a patient when the ac power supply indicator unexpectedly disappeared from the screen, and the system automatically switched to battery mode.Upon inspection, it was found that the internal fuses had blown.Replacement fuses were installed; however, they blew immediately upon powering on the device.The issue has been reported to the xenios service team for further investigation and they suggested to return the console to xenios.There was no resulting patient serious injury.The complaint sample was available for product investigation.
Additional Manufacturer Narrative
Additional information: b5, d9.H6 plant investigation: nonconformity was not observed during the manufacturing process.The review of the repair history of this console showed no repair activities.Upon inspection, it was found that the internal fuses had blown.Replacement fuses were installed; however, they blew immediately upon powering on the device.The power supply board was received and forwarded to the supplier for investigation.A defect in the return power supply board was confirmed.A definitive cause for the defect could not be found.It was determined 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 main power supply.The defective parts involved have been replaced and the unit was retested as it provided the correct output voltage as expected.
Event or Problem Description
A user facility reported that the novalung console was in use on a patient when the ac power supply indicator unexpectedly disappeared from the screen, and the system automatically switched to battery mode.Upon inspection, it was found that the internal fuses had blown.Replacement fuses were installed; however, they blew immediately upon powering on the device.The issue was reported to the xenios service team for further investigation and they suggested to return the console to xenios.There was no resulting patient serious injury.The complaint sample was returned to 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: 22564072
• Report Number: 3012172416-2025-00072
• Device Sequence Number: 17119522
• 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): 02/02/2026

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: 07/02/2025
• Supplement Date Received by Manufacturer: 01/28/2026
• Initial Report FDA Received Date: 07/22/2025
• Supplement Report FDA Received Date: 02/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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