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

Model Number	ALLURA XPER FD10
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to philips that the system was unable to boot up correctly.The device was outside of clinical use at the time of the reported event.No harm was reported to philips.Philips has started an investigation of this complaint.
Additional Manufacturer Narrative
Philips has investigated this complaint.A philips field service engineer (fse) visited onsite and confirmed that the system failed to boot up due to the physio box (non-philips product) connection to the host pc.Fse removed the physio-box connection which resolved the issue, as system start up completed successfully.After that, the system was returned in good working condition and was ready for clinical use.The codes were updated based on the investigation outcome.
Additional Manufacturer Narrative
Philips has investigated this complaint.A philips field service engineer (fse) visited onsite and confirmed that the system failed to boot up due to the physio box (non-philips product) usb connection to the host pc.A physio box is used to integrate the ecg line from a hemodynamic system into the xray series images.The fse removed the physio-box connection which resolved the issue, as system start up completed successfully.The physio box connection is not essential for the system to function, and since the customer confirmed that the ecg overlay was not necessary, the physio box was left disconnected.After that, the system was returned in good working condition and was ready for clinical use.To date, there have been no reoccurrences of this issue.At the time this complaint was received, philips did not have enough information to exclude a product malfunction with the potential for death or serious injury on recurrence, and as such the complaint was reported.Since that time, new information has been received which has led to the determination that this scenario is not likely to cause or contribute to death or serious injury if it were to recur.Investigation has confirmed that the reported boot up issue was related to a third-party component, and that there was no malfunction of the philips system.Since the philips system has not malfunctioned, 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: derrick massuri ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 20816752
• Report Number: 3003768277-2024-006944
• Device Sequence Number: 7636889
• Product Code: OWB
• UDI-Device Identifier: 00884838059191
• UDI-Public: (01)00884838059191
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 09/09/2025

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: ALLURA XPER FD10
• Device Catalogue Number: 722026
• 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: 11/22/2024
• Supplement Date Received by Manufacturer: 05/14/2025; 05/14/2025
• Initial Report FDA Received Date: 12/02/2024
• Supplement Report FDA Received Date: 06/13/2025; 09/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2016
• 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
• Patient Sex: Unknown