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 Radiation Output Failure (4027)

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

Event Date 12/03/2023

Event Type  malfunction  

Event Description

It has been reported to philips that image storage was not available, which would prevent imaging.The device was in clinical use at the time of the event.The patient had to be taken off the table and moved to another room.No harm to the patient or user was reported.Philips has started an investigation of this complaint.

Manufacturer Narrative

Philips has investigated this complaint.The philips field service engineer (fse) inspected the system onsite and confirmed that the reported problem.The defective parts, ip pc revised ii no hdd and ip revised -2 pc no hdd were returned for analysis and for ip pc revised ii no hdd the failure analysis concluded that no failure was found and for ip revised -2 pc found that there was a configuration issue, failed in pci check for gpu.However, fse replaced both frontal and lateral ippc, os and image disks, reloaded os, and application software, recreated the image storage and created system back up.After replacement the system was returned to use in good working order.

• 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: 18420700
• MDR Text Key: 331667072
• Report Number: 3003768277-2023-07275
• Device Sequence Number: 1
• Product Code: IZI
• UDI-Device Identifier: 00884838059061
• UDI-Public: 00884838059061
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130842
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: 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

• 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
• Initial Date Manufacturer Received: 12/03/2023
• Initial Date FDA Received: 12/29/2023
• Supplement Dates Manufacturer Received: 02/20/2024
• Supplement Dates FDA Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2012
• 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