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

Model Number ALLURA XPER FD20

Device Problem Image Display Error/Artifact (1304)

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

Event Date 01/13/2023

Event Type  malfunction  

Event Description

It has been reported to philips that the machine is not working smoothly.The device was in clinical use.No patient harm reported.The system was rebooted and did not resolve the problem.The field service engineer went on site and the diagnosis is exposure and the image view are crashing.The ippc hard disc error.Exchange image disc and re-create database.Philips has started an investigation of the complaint.

Manufacturer Narrative

Philips has investigated this complaint.The philips field service engineer (fse) inspected the system onsite and confirmed that the software was stuck.The fse performed the troubleshooting and found that the "post frontal ip-pc image disk 1" had failed.Checked cable connections on ippc and found them to be in good condition, checked os and image disks on ippc, bypassed image disk 1 and found it to be in bad condition, verified image store data consistency and database consistency, and found them to be in bad condition.The fse replaced the image disk and recreated the database.After the replacement of image disk and recreating the database, 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: 16292772
• MDR Text Key: 308842408
• Report Number: 3003768277-2023-00716
• Device Sequence Number: 1
• Product Code: IZI
• UDI-Device Identifier: 00884838059054
• UDI-Public: 00884838059054
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K130842
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ALLURA XPER FD20
• Device Catalogue Number: 722012
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/12/2015
• 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