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	09/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It has been reported to philips that the system failed to boot up.The system was not in clinical use.There was no reported patient or user harm.A philips field service engineer (fse) inspected the system onsite and confirmed the reported problem.Troubleshooting actions showed a problem with the flexvision pc.After the flexvision pc was replaced and the software was reinstalled, the system was returned to use in good working order.
Additional Manufacturer Narrative
Philips has investigated this complaint.A philips field service engineer (fse) inspected the system onsite and confirmed that the system failed to boot up.After reviewing the log file, fse found that the grabber card failure and the flex vision pc is defective.Fse replaced flex vision pc and installed software.After the replacement of the flex vision pc, the system returned to use in good working order.The defective part was returned for analysis, and it confirmed that the failed component(s) were allura haswell flex vision 2 pc.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: dusty leppert ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 17965067
• Report Number: 3003768277-2023-05703
• Device Sequence Number: 6565785
• Product Code: OWB
• UDI-Device Identifier: 00884838059122
• UDI-Public: 00884838059122
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2023
• Supplement Date Received by Manufacturer: 04/17/2024
• Initial Report FDA Received Date: 10/19/2023
• Supplement Report FDA Received Date: 04/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/19/2018
• 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
• Patient Sex: Unknown