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

Model Number	ALLURA XPER FD20/15 OR TABLE
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to philips that the system would not bootup.The device was in clinical use at the time of the reported event.No harm was reported to philips.Philips has started an investigation of this compliant.
Additional Manufacturer Narrative
Philips has investigated this complaint.According to the additional information collected, the issue occurred during the diagnosis and the procedure was completed by moving the patient to another room.Philips field service engineer (fse) inspected the system onsite and confirmed that the system was not starting.Upon troubleshooting actions, fse identified that the host pc was unable to read the hard drive.Fse replaced the hard drive and restored the ghost software, but issue was not resolved.The defective host pc was returned for analysis, and it was concluded that the failed component was power supply unit (psu).Fse replaced host pc and hard drive.After replacement, the system was returned to use in good working order.The codes were updated based on the investigation outcome.
Additional Manufacturer Narrative
This report was submitted to provide the linkage to an existing correction and removal (3003768277-12/28/2023-010-c).The reported event occurred prior to completion of the field correction 3003768277-12/28/2023-010-c, which addresses the causes associated with the reported malfunction.

• 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: 19709434
• Report Number: 3003768277-2024-03756
• Device Sequence Number: 11542224
• Product Code: OWB
• UDI-Device Identifier: 00884838059122
• UDI-Public: 00884838059122
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K141979
• 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
• Remedial Action: Repair
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/17/2025

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 FD20/15 OR TABLE
• Device Catalogue Number: 722059
• 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: 06/24/2024
• Supplement Date Received by Manufacturer: 08/28/2024; 09/24/2024
• Initial Report FDA Received Date: 07/10/2024
• Supplement Report FDA Received Date: 08/29/2024; 01/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2018
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 3003768277-12/28/2023-01
• Patient Sequence Number: 1
• Patient Sex: Unknown