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

Model Number ALLURA XPER FD20 BIPLANE

Device Problems Unintended System Motion (1430); Malposition of Device (2616)

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

Event Date 06/14/2023

Event Type  malfunction  

Event Description

It has been reported to philips that when the geometry reset button was pressed, the allura table cradled unexpectedly.The device was inside of clinical use at the time of the event.No harm was reported to philips.Philips has started an investigation of this complaint.

Manufacturer Narrative

A philips service engineer evaluated the system; error logs were checked, and no errors were recorded.The problem was not able to be duplicated.No evidence of a malfunction was found.The investigation has not yet been completed.A final report will be sent when the investigation is complete.

Manufacturer Narrative

Philips has investigated this complaint.According to the additional information collected, the issue occurred during a diagnosis of vascular procedure and the procedure was completed as planned by restarting the system.The philips field service engineer (fse) inspected the system onsite and was unable to replicate the reported problem.The fse reviewed error logs and determined that there were no errors and the fse suspected that the tso buttons were operated incorrectly.Since the fse confirmed that the device was working as intended, the device was returned to use in good working order.The codes were updated based on the investigation outcome.The device problem code was corrected.

• 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: 17296994
• MDR Text Key: 318745820
• Report Number: 3003768277-2023-03988
• 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,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: 06/14/2023
• Initial Date FDA Received: 07/11/2023
• Supplement Dates Manufacturer Received: 07/12/2023; 10/03/2023
• Supplement Dates FDA Received: 08/11/2023; 11/10/2023
• 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