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	01/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility reported that at 13:47 (local time), #00a technical fault occurred during treatment.The drive pump would not work and the nurse could not reset this alarm.The user decided to utilize the backup drive pump for continued support.The user facility has reported this record to their local nmpa.A technical services representative inspected the device, tested the cabling and observed actual flow of the pump drive.There was no fault in the device found.There was no patient serious injury.The complaint sample was not returned to the manufacturer.
Additional Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
Additional Manufacturer Narrative
Additional information: h4, h6 plant investigation: non-conformity was not observed during the manufacturing process.Final inspection resulted with conformity.No other complaint has been reported about this console.The review of the repair history of this console showed two repair activities related to this complaint.Onsite evaluation by technical services showed no fault in the main pump.The cause of the main pump alarms may have been a sporadic communication problem.The review of machine files provided by the user facility indicate short disconnections of the pump drive and/or sensor box.Both components were restarting within a few seconds each time.This could have been caused by a defective sensor box and/or pump drive cable, or improperly seated connectors.The device has been in use without repair and is currently functioning normally.
Event or Problem Description
A user facility reported that at 13:47 (local time), #00a technical fault occurred during treatment.The drive pump would not work and the nurse could not reset this alarm.The user decided to utilize the backup drive pump for continued support.The user facility has reported this record to their local nmpa.A technical services representative inspected the device, tested the cabling and observed actual flow of the pump drive.There was no fault in the device found.There was no patient serious injury.The complaint sample was not returned to the manufacturer.

• 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: 24843613
• Report Number: 3012172416-2026-00027
• Device Sequence Number: 12993529
• Product Code: QJZ
• UDI-Device Identifier: 04057224902043
• UDI-Public: 04057224902043
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 04/22/2026

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?: No
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2026
• Supplement Date Received by Manufacturer: 04/21/2026
• Initial Report FDA Received Date: 04/10/2026
• Supplement Report FDA Received Date: 04/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2023
• 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