MAUDE Adverse Event Report: LIEBEL-FLARSHEIM BASE SYSTEM, ILLUMENA

Model Number	900006C
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
This case was reported by a facility in (b)(6), china on 07 july 2025.Customer reports that at around 9 a.M.On (b)(6) 2025, during the patient's treatment, the high-pressure injector's screen went black and showed error code "0013".The technician rebooted the device several times, but still couldn't enable the surgery to continue, so the surgery had to be suspended.Product name: high-pressure injector type of injury: serious injury manifestation: during a patient's cerebral angiography procedure, the high-pressure injector stopped working during surgery, the device went black screen and prompt error code "0013".As a result, the surgery was suspended, and the patient will need to undergo the surgery again on another day.This incident seriously endangered the patient's life safety, causing secondary harm and negatively impacting the hospital department's surgery and reputation.Device malfunction performance: during the surgery, the high-pressure injector stopped working.A black screen error code "0013" appeared.The device was rebooted several times, but it still couldn't support the continuation of the surgery.It kept turning on but showing a black screen with error code "0013".Expected treatment for the disease or effect: to ensure rapid and accurate injection of a sufficient amount of high-concentration x-ray contrast media into the examination site within a certain period, enabling diagnostic angiography and treatment of the lesion.As a contrast media delivery system, it is used to inject radiopaque contrast media into the patient's vascular system to obtain diagnostic-grade images when using computed tomography device.Use process: at around 9 a.M.On (b)(6) 2025, during the patient's treatment, the high-pressure injector's screen went black and showed error code "0013".The technician rebooted the device several times, but still couldn't enable the surgery to continue, so the surgery had to be suspended.
Additional Manufacturer Narrative
Overall investigation summary: a complaint was received on angiomat illumena 900006c serial number (b)(6) alleging an error code pp0013, which indicates the power pack failed to establish communication with the powerhead.Regional service was dispatched and confirmed the alarm on the system.When the service engineer cycled power during troubleshooting, it was found that the system was operating normally.It was noted that there may have been poor cable connection at the port; after reconnecting the cables, there were no further issues noted and the system was returned to customer use.One potential cause for poor connection of the powerhead cable is repeated moving of the system and/or cable and not checking that the cable has remained tightly connected.A review of guerbet's complaint tracking system shows no previously eported pp0013 but does indicate that a communications alarm (pp0005) was reported.In the case of the pp0005, the system was rebooted and returned to normal use.Impact assessment summary no injury to the patient/user reported imdrf codes: b01; c02, c0205; d15.Root / probable cause code adjustment-loose cable root / probable cause summary refer to investigation summary.No additional capa required at this time.Guerbet quality will continue to monitor and trend for similar issues.These trends and issues are reported on during quality metrics review and during the management reviews to consider input for additional corrective action.Disposition summary unit returned to service.

• Brand Name: BASE SYSTEM, ILLUMENA
• Common Device Name: BASE SYSTEM, ILLUMENA
• Manufacturer (Section D): LIEBEL-FLARSHEIM; 2111 e. galbraith rd; cincinnati
• Manufacturer Contact: jacob miller ; 2111 e. galbraith rd; cincinnati, OH 45237 ; 5139485765
• MDR Report Key: 22716184
• Report Number: 1518293-2025-00011
• Device Sequence Number: 18425041
• Product Code: DXT
• UDI-Device Identifier: 10746190002802
• UDI-Public: 0110746190002802
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K963071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other,Inspection
• Type of Report: Initial
• Report Date (Section B): 08/04/2025

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: 900006C
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2025
• Initial Report FDA Received Date: 08/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/30/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown