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

Model Number ALLURA XPER FD20 BIPLANE

Device Problem No Display/Image (1183)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/03/2024

Event Type  malfunction  

Event Description

It was reported to philips that the live image was not displaying.No patient or user harm was reported.A philips field service engineer (fse) inspected the system onsite and replaced the flexvision computer which resolved the issue.The device was returned to use in good working order.

Manufacturer Narrative

Philips has investigated this complaint.According to the additional information collected, system was in clinical use.The customer intended to perform a planned treatment/non-emergency treatment procedure.However, the patient was moved to the next room and the procedure was completed as planned.The philips field service engineer (fse) inspected the system onsite and confirmed the front live image was not displaying in the flexvision pc.Review of system log file confirm the malfunctioning of flexvision pc.Upon troubleshooting, fse found that the signal switching function (layout change) was not being controlled correctly.To resolve this issue, the philips engineer replaced the flexvison pc and reinstalled software.The defective module was returned to philips for further analysis.The analysis could not confirm the failure.After replacement of flexvision pc and reinstalling software, the system was returned to use in good working order.The codes were updated based on the investigation outcome.

• Brand Name: ALLURA XPER FD
• Type of Device: 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: 18624562
• MDR Text Key: 334338136
• Report Number: 3003768277-2024-00594
• Device Sequence Number: 1
• Product Code: IZI
• UDI-Device Identifier: 00884838059061
• UDI-Public: 00884838059061
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K130842
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ALLURA XPER FD20 BIPLANE
• Device Catalogue Number: 722013
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1