MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALLURA XPER FD; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number	ALLURA XPER FD20/20
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to philips that renal biopsy procedure the table¿s longitudinal movement did not perform as intended which delayed an examination.The report indicated that an injury occurred; however, no further details regarding the alleged injury have been provided at this time.An investigation into this complaint has been initiated by philips.
Additional Manufacturer Narrative
Philips investigated the reported complaint.Based on the information obtained, the issue occurred prior to patient preparation and entering the examination room.The renal biopsy procedure was rescheduled and later completed successfully, after which the patient was discharged.A philips field service engineer (fse) was dispatched to the customer site and confirmed the reported issue.Review of the system log files showed an ¿application error: ethercat post error,¿ indicating a malfunction of the amc ecat drive.The fse replaced the amc ecat drive, which resolved the issue.The system was repaired, tested, and returned to clinical use in good working condition.The codes were updated based on the investigation outcome.

• Brand Name: ALLURA XPER FD
• Common Device Name: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer Contact: marjan vos ; veenpluis 6; best 5684 -PC ; NL 5684 PC
• MDR Report Key: 23535289
• Report Number: 3003768277-2025-014506
• Device Sequence Number: 10187150
• Product Code: OWB
• UDI-Device Identifier: 00884838054226
• UDI-Public: (01)00884838054226
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K162859
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: ALLURA XPER FD20/20
• Device Catalogue Number: 722038
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2025
• Supplement Date Received by Manufacturer: 01/21/2026
• Initial Report FDA Received Date: 11/12/2025
• Supplement Report FDA Received Date: 02/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2018
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown