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

Model Number	ALLURA XPER FD10
Medical Device Problem Code	Radiation Output Failure (4027)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to philips that the system was unable to perform cine.The patient was moved to another system to complete the procedure.The system was in clinical use at the time of the event.No harm was reported to philips.Philips has started an investigation of this complaint.
Additional Manufacturer Narrative
Philips investigated this complaint.According to the information collected the system was not in clinical use at the time of the event.The philips remote service engineer(rse) examined system remotely and confirmed the issue.The philips field service engineer (fse) found that the sensor in the uts (universal transfer switch) was not functioning which prevented the system from being placed into bypass mode for normal fluoroscopy and cine.Upon further investigation, fse identified that the teal power conditioner failed due to the teal internal power supply failure and temporarily the system would only functioning in low power fluoro mode.The replacement of ups was suggested by the fse which would resolve the issue permanently.To date, there have been no further reports of this issue.At the time this complaint was received, philips did not have enough information to exclude the potential for death or serious injury on recurrence, and as such the complaint was reported.Since that time, it was identified that the issue occurred without patient involvement and was identifiable prior to procedure commencement, which has led to the determination that this is scenario is not likely to cause or contribute to death or serious injury if it were to recur.As per the instructions for use, the user of the product must institute a user routine checks program.The user of the product shall make sure that all checks and actions have been satisfactorily completed before using the product for its intended purpose.It is instructed to not use the product for any application until the user is sure that the user routine checks have been satisfactorily completed, therefore, as the device was outside of use at the time the issue was identified, the user would identify this issue prior to use.Based on re-evaluation, this case is not reportable.The codes have been updated based on the investigation outcome.

• Brand Name: ALLURA XPER FD
• Common Device Name: SYSTEM, X-RAY, ANGIOGRAPHIC
• 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: 23994731
• Report Number: 3003768277-2026-100075
• Device Sequence Number: 10185129
• Product Code: IZI
• UDI-Device Identifier: 00884838059030
• UDI-Public: (01)00884838059030
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K130842
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2026

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 Model Number: ALLURA XPER FD10
• Device Catalogue Number: 722010
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2025
• Supplement Date Received by Manufacturer: 02/20/2026
• Initial Report FDA Received Date: 01/07/2026
• Supplement Report FDA Received Date: 02/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2013
• 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