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

Model Number ALLURA XPER FD20

Device Problem Activation Failure (3270)

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

Event Date 12/20/2023

Event Type  malfunction  

Event Description

It was reported to philips that the allura system did not start.The device was outside of clinical use at the time of the reported event, no harm was reported to philips.As per the field service engineer, the host pc was faulty.Philips has started an investigation of this complaint.

Manufacturer Narrative

Philips has investigated this complaint.A philips field service engineer (fse) inspected the system on-site.The system log files were analyzed which did not indicate a malfunction, however as the host pc is responsible for maintaining the logging and it was alleged that the host pc would not boot, this is expected.As part of troubleshooting, all plugs on the host pc were checked and hard disks were reinserted.The fse successfully restarted the system without error.However, due to the intermittent start-up problem, the fse replaced the host pc and hard disk as a precautionary measure, reloaded the software and configured the new pc.The cause of the host pc failure could not be conclusively determined by the supplier¿s part analysis; however, the replacement of host pc by the fse has resolved the reported issue and restored the functionality of the system.After replacement of the host pc, the system was returned to use in good working order.

• 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: derrick massuri ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 18418191
• MDR Text Key: 331587951
• Report Number: 3003768277-2023-07264
• Device Sequence Number: 1
• Product Code: IZI
• UDI-Device Identifier: 00884838059054
• UDI-Public: 00884838059054
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Report Date: 07/15/2024

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: 12/20/2023
• Initial Date FDA Received: 12/29/2023
• Supplement Dates Manufacturer Received: 06/26/2024
• Supplement Dates FDA Received: 07/15/2024
• 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