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

Model Number ALLURA XPER FD20 OR TABLE

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 07/27/2023

Event Type  malfunction  

Event Description

It has been reported to philips that the allura xper fd20 or table system flexmove transversal bearing was loose.The system was not in clinical use and no harm has been reported.Upon evaluation it was determined that the wrong strip was on the flexmove component.The strip was replaced, and the system was returned to functionality.

Manufacturer Narrative

Philips has investigated this complaint.A philips service engineer inspected the system onsite and confirmed that 4 loose bolts were found, and a metal strip is missing.The metal strip prevents play between the metal block and the linear bearing, and additional shear stress to the bolts.The c-arc is connected to the metal block.Upon some functional test fse arranged a new metal strip was.The fse installed the metal strip and mounted the bolts with loctite, after installing the flexarm metal strip, 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: 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: 17498457
• MDR Text Key: 320808977
• Report Number: 3003768277-2023-04361
• Device Sequence Number: 1
• Product Code: OWB
• UDI-Device Identifier: 00884838059085
• UDI-Public: 00884838059085
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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

• Date FDA Received: 08/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ALLURA XPER FD20 OR TABLE
• Device Catalogue Number: 722023
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/22/2013
• 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