MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALLURA XPER FD10; SYSTEM, X-RAY, ANGIOGRAPHIC

Model Number ALLURA XPER FD10

Device Problem Radiation Output Failure (4027)

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

Event Date 04/15/2024

Event Type  malfunction  

Event Description

It was reported to philips that the device gave an alert indicating the system's disk bay board was degraded, which can impact imaging.The system was in clinical use and the patient was moved to another room to complete the procedure.There was no reported patient or user harm.A philips field service engineer (fse) replaced the disk bays in the image processing computer and the host computer.After the replacement of the disk bays the system was returned to use in good working order.

Manufacturer Narrative

Philips has investigated this complaint.Analysis of the log file confirmed the malfunction with image processing pc(ippc) indicating that the most likely cause of the event was disk bay.A field service engineer(fse) inspected the system onsite and replaced drive bays in host pc and ippc.Philips has confirmed that the reported failure is due to a disk bay failure.Due to the disk bay failure, the system may not perform as intended and may stop functioning and imaging may not be possible, resulting in delay of procedure.Philips has initiated a medical device correction (z-1151-2024) /field safety corrective action (2023-igt-bst-027).The correction has been scheduled to be implemented on the system.The system is currently being used after replacement of the disk drive bays.The codes were updated based on the investigation outcome.

• Brand Name: ALLURA XPER FD10
• 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: 19214480
• MDR Text Key: 341420616
• Report Number: 3003768277-2024-02531
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K041949
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/02/2024

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 FD10
• Device Catalogue Number: 722003
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/15/2024
• Initial Date FDA Received: 04/30/2024
• Supplement Dates Manufacturer Received: 06/17/2024
• Supplement Dates FDA Received: 07/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: Z-1151-2024
• Patient Sequence Number: 1