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

Model Number	ALLURA XPER FD20
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to philips that the ceiling protective cover fell off.No harm was reported to philips.Philips has started an investigation of this complaint.
Additional Manufacturer Narrative
Philips has investigated this complaint.According to the additional information collected, the system was outside of clinical use when the issue occurred.The philips field service engineer inspected the system onsite and identified that the protective ceiling cover had fallen because the safety chain lacked a proper mounting location and was temporarily secured with cable ties.To resolve this issue, fse replaced the ceiling cover.The failure of the protective ceiling cover can be attributed to the issues resolved in philips correction 2023-igt-bst-002.After replacement, the system was returned to use in good working order.The codes have been updated based on the investigation's 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: 21661356
• Report Number: 3003768277-2025-002672
• Device Sequence Number: 12923372
• Product Code: IZI
• UDI-Device Identifier: 00884838059191
• UDI-Public: (01)00884838059191
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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,Followup
• Report Date (Section B): 06/12/2025

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: 722012
• 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: 03/07/2025
• Supplement Date Received by Manufacturer: 06/11/2025
• Initial Report FDA Received Date: 03/21/2025
• Supplement Report FDA Received Date: 06/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/09/2017
• 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