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

Model Number ALLURA XPER FD20

Device Problem Unintended System Motion (1430)

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

Event Date 06/17/2023

Event Type  malfunction  

Event Description

It has been reported to philips that when the stand was rotated, angulation movement was also occurring.The system was in clinical use at the time of the reported event.There was no report of harm.A philips field service engineer (fse) inspected the device onsite and replaced the geo module wp kit.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 angulation rotation also moves during stand rotation.Review of the system log file does not contain any ui module and geometry related malfunction.As a part of troubleshooting action fse identified that geo module is defective.Fse replaced the geo module kit.After the replacement of geo module kit, 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: dusty leppert ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 17309304
• MDR Text Key: 319008467
• Report Number: 3003768277-2023-04020
• Device Sequence Number: 1
• Product Code: IZI
• UDI-Device Identifier: 00884838059054
• UDI-Public: 00884838059054
• 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

• 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: 06/17/2023
• Initial Date FDA Received: 07/12/2023
• Supplement Dates Manufacturer Received: 09/14/2023
• Supplement Dates FDA Received: 09/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/07/2014
• 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