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

Model Number ALLURA XPER FD20

Device Problem Display or Visual Feedback Problem (1184)

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

Event Date 04/24/2023

Event Type  malfunction  

Event Description

It has been reported to philips that the live screen was faulty.The system was in clinical use.No harm has been reported to philips.A philips service engineer inspected the system on site and found that the display did not lit up.Troubleshooting actions showed a problem with exam room monitor.The fse replaced exam room monitor and the system was returned to use in good working order.

Manufacturer Narrative

Philips has investigated this complaint.The philips field service engineer (fse) inspected the system onsite and confirmed that the system live screen is faulty.Trouble shooting action showed that the monitor failed and there was no display.Fse replaced the monitor, and the system was returned to use in good working order.The codes were updated based on the investigation outcome.Evaluation method code was corrected.

• Brand Name: ALLURA XPER FD
• Type of Device: 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: 16860379
• MDR Text Key: 314459433
• Report Number: 3003768277-2023-02642
• Device Sequence Number: 1
• Product Code: OWB
• UDI-Device Identifier: 00884838059054
• UDI-Public: 00884838059054
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K130638
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Initial Date Manufacturer Received: 04/24/2023
• Initial Date FDA Received: 05/03/2023
• Supplement Dates Manufacturer Received: 05/17/2023
• Supplement Dates FDA Received: 09/20/2023
• 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