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

Model Number	ALLURA XPER FD20/15 OR TABLE
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to philips that the c-arm propeller movement was not working properly.The device was in clinical use at the time of the reported event.No harm to the patient or user was reported.Philips has investigated this complaint.According to the additional information collected, the issue during the neurovascular treatment.The procedure was completed after calibrating the system.The philips field service engineer (fse) inspected the system onsite and identified that the customer was unable to fully rotate the frontal c-arm detector, which resulted in the c-arm propeller being immobile.Fse calibrated the c-arm.After calibration, the system was returned to use in good working order.

• 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: derrick massuri ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 20404880
• Report Number: 3003768277-2024-05759
• Device Sequence Number: 6545885
• Product Code: IZI
• UDI-Device Identifier: 00884838059122
• UDI-Public: 00884838059122
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/09/2024

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2024
• Initial Report FDA Received Date: 10/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/26/2019
• 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