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

Model Number ALLURA XPER FD20 BIPLANE

Device Problem Positioning Failure (1158)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/01/2020

Event Type  malfunction  

Event Description

It was reported to philips that during a neuro emergency procedure the geo ipc did not start after reboot.No system movements were possible.No harm has been reported to philips.Philips has started the investigation of this complaint.

Event Description

Follow up: philips has investigated this complaint according to the information collected, the patient was moved to another room where the procedure was completed successfully with no harm to the patient.The customer reported that during the procedure there were problems with the ad7 table.The system was rebooted due to these ad7 table problems and after the reboot no geometry movements were possible.Philips inspected the system on site and the log files and confirmed the failure of the geo-ipc (geometry pc).The analysis of the log files did not show any malfunction of the ad7 table.The geo-ipc was replaced after which the system was returned to use in good working order with no reoccurrence.

• Brand Name: ALLURA XPER FD
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 4-6; best 5684 PC; NL 5684 PC
• MDR Report Key: 10689718
• MDR Text Key: 211758616
• Report Number: 3003768277-2020-01010
• Device Sequence Number: 1
• Product Code: IZI
• UDI-Device Identifier: 00884838059061
• UDI-Public: 00884838059061
• Combination Product (y/n): N
• PMA/PMN Number: K130842
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• 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 BIPLANE
• Device Catalogue Number: 722013
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 10/01/2020
• Initial Date Manufacturer Received: 10/01/2020
• Initial Date FDA Received: 10/16/2020
• Supplement Dates Manufacturer Received: 10/01/2020
• Supplement Dates FDA Received: 02/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other