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 Problems Unstable (1667); Positioning Problem (3009)

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

Event Date 09/14/2022

Event Type  malfunction  

Event Description

It was reported to philips that the c-arm roll spin was erratic.The device was reported as being used for treatment at the time of the event.No harm has been reported to philips.Philips has started an investigation for this complaint.

Manufacturer Narrative

Philips has investigated this complaint.According to the additional information, the system was in clinical use and the ct spin diagnostic procedure has been completed without abdominal spin.Fse relieved the tension in the c-arm cable and re-calibrated the bodyguard.The engineer performed several to tests and unable to reproduce the reported issue.The configuration of the c-arm service software and database were also correct.The system was returned to use in good working order.The codes were updated based on the investigation outcome.Device problem code was corrected.

• 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
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 4-6; best 5684 PC; NL 5684 PC
• Manufacturer Contact: dusty leppert ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 15594318
• MDR Text Key: 302088346
• Report Number: 3003768277-2022-00504
• Device Sequence Number: 1
• Product Code: OWB
• UDI-Device Identifier: 00884838059061
• UDI-Public: 00884838059061
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130638
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2022
• 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?: Yes
• Date Manufacturer Received: 08/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/08/2011
• 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