MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALLURA XPER FD20; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number	ALLURA XPER FD20
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Philips has investigated this complaint.The philips field service engineer (fse) inspected the system onsite and confirmed that the system was unable to turn on.Upon functional testing, the fse found that the main circuit breaker supplying power to the system was tripped.The fse reset the breaker, which restored power to the system.Upon further analysis, one of the circuit breakers inside the m-cabinet was tripped and also found a wiring issue.To resolve the issue, fse did the soldering the broken wire back into place and then reset the tripped circuit breaker in the m-cabinet.After repair, the system was returned to use in good working order.The codes were updated based on the investigation outcome.
Event or Problem Description
It was reported to philips that the system was unable to boot up after a power outage.The device was outside of clinical use at the time of reported event.No harm was reported to philips.Philips has started an investigation of this complaint.

• Brand Name: ALLURA XPER FD20
• 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: 22475914
• Report Number: 3003768277-2025-006286
• Device Sequence Number: 18128512
• Product Code: OWB
• UDI-Device Identifier: 00884838059191
• UDI-Public: (01)00884838059191(10)1.5.1.1044
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K033737
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2025

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 FD20
• Device Catalogue Number: 722006
• 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: 07/06/2025
• Supplement Date Received by Manufacturer: 07/31/2025
• Initial Report FDA Received Date: 07/10/2025
• Supplement Report FDA Received Date: 08/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2009
• 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