MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALLURA XPER FD10; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number ALLURA XPER FD10

Device Problem Unintended System Motion (1430)

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

Event Date 10/16/2023

Event Type  malfunction  

Event Description

It was reported to philips that when the mushroom pan knob was released the table still moved.No user or patient harm has been reported.Philips has started an investigation regarding the reported issue.

Manufacturer Narrative

Philips has investigated this complaint.According to additional information collected the coronary diagnosis/emergency treatment was completed by using separate pan handle.The philips field service engineer (fse) inspected the system onsite and confirmed that when the mushroom pan knob was released the table still moved.Review of system logfile didn¿t contain ¿geo module mushroom button¿ malfunction.Upon functional testing fse found that the table side geo module mushroom button was not always braking correctly.To resolve the issue fse swapped geo module with one from control room.After this, the system was returned to use in good working order.The codes were updated based on the investigation outcome.

• Brand Name: ALLURA XPER FD10
• 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: 17994882
• MDR Text Key: 326368289
• Report Number: 3003768277-2023-05783
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K041949
• 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 Health Care Professional
• 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 FD10
• Device Catalogue Number: 722003
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/16/2023
• Initial Date FDA Received: 10/24/2023
• Supplement Dates Manufacturer Received: 01/11/2024
• Supplement Dates FDA Received: 01/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/26/2008
• 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