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

Model Number ALLURA XPER FD20 BIPLANE

Device Problem Difficult or Delayed Activation (2577)

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

Event Date 11/15/2023

Event Type  malfunction  

Event Description

It has been reported to philips that system was taking a long time to start up.The device was in clinical use at the time of the reported event.No harm has been reported to philips.Philips has started an investigation of this complaint.

Manufacturer Narrative

Philips has investigated this complaint.According to additional information collected, the system was not in clinical use when the issue was identified.The philips remote service engineer (rse) inspected the system remotely and found that the system was taking a long time to start up.Review of the log files confirmed the reported malfunction.The rse performed the system troubleshooting and found that the analysis software was not starting properly and the system was taking longer time for the software to start up.The rse suspected the data was fragmented and advised the customer to delete the old data.The cause of the issue was with the host pc.The issue was resolved when the customer selected the proper hdd (hard disk drive) bootup sequence.After the repair, the system 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: derrick massuri ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 18300231
• MDR Text Key: 330159246
• Report Number: 3003768277-2023-06864
• Device Sequence Number: 1
• Product Code: IZI
• UDI-Device Identifier: 00884838059061
• UDI-Public: 00884838059061
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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

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: 11/15/2023
• Initial Date FDA Received: 12/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/26/2012
• 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