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

Model Number	ALLURA XPER FD20/10
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to philips that during an angiographic procedure, the c-arm did not return to the home position.The report indicated that an injury occurred; however, no further details regarding the alleged injury have been provided to date.An investigation into this complaint has been initiated by philips.
Additional Manufacturer Narrative
The investigation into this complaint is still ongoing; however, additional information has been received indicating that the event occurred during a planned, non-emergent procedure that was completed as intended after the customer restarted the system.Further information verified that no harm occurred to the patient.At the time this complaint was received, philips did not have sufficient information to exclude the potential for serious injury, so the complaint was reported.A final report will be submitted once it is complete.Codes have been updated to reflect the new information received.
Additional Manufacturer Narrative
Philips has investigated this complaint.According to additional information received, during the event, the 3d imaging could not be performed due to the c-arm did not returning to its home position.A philips field service engineer (fse) inspected the system onsite and confirmed that the base rotation potentiometer was checked and showed unstable values.Additionally, the system log file review confirmed the reported issue with ¿application error: post failed: cle-2>, bas position,¿ followed by the user message ¿warning: motorized movement unavailable.¿ an additional warning, ¿application error: warning on [movement=beamzrotation].¿ based on onsite findings, intermittent instability of the base rotation potentiometer was associated with the gantry not reaching its home position and the related inability to perform 3d imaging.To resolve the reported issue, the fse replaced the potentiometer assy, and calibration of the main arm and rotation sensor was performed.Following these actions, functional verification confirmed that the system was operating within specifications and was returned to clinical use.Subsequent findings confirmed that the patient was not harmed and that the issue was resolved through a system restart, allowing the procedure to proceed.As such, this complaint has been re-evaluated as not reportable.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: 23750893
• Report Number: 3003768277-2025-015604
• Device Sequence Number: 9321354
• Product Code: OWB
• UDI-Device Identifier: 00884838054219
• UDI-Public: (01)00884838054219
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Followup
• Report Date (Section B): 02/25/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: ALLURA XPER FD20/10
• Device Catalogue Number: 722029
• 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: 11/28/2025
• Supplement Date Received by Manufacturer: 12/08/2025; 02/23/2026
• Initial Report FDA Received Date: 12/08/2025
• Supplement Report FDA Received Date: 01/09/2026; 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/27/2018
• 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