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

Model Number ALLURA XPER FD10

Device Problem Activation Failure (3270)

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

Event Date 04/21/2024

Event Type  malfunction  

Event Description

It was reported to philips that the system did not boot up successfully.No harm was reported to philips.The field service engineer replaced the hard disk and the system was returned to use in good working order.

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 field service engineer (fse) inspected the system onsite and confirmed that system could not boot up.Review of the log file didn't confirm the reported malfunction.It was identified that the host pc hard disk was not detected and the system os (operating system) & application did not boot.The fse performed system troubleshooting and found that the host pc os disk failed and couldn't be detected on the system.So, the fse replaced it with a new os disk and reloaded the software to resolve the issue.After the replacement, 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: derrick massuri ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 19193938
• MDR Text Key: 341195518
• Report Number: 3003768277-2024-02474
• Device Sequence Number: 1
• Product Code: IZI
• UDI-Device Identifier: 00884838059030
• UDI-Public: 00884838059030
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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

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: 722010
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/21/2024
• Initial Date FDA Received: 04/26/2024
• Supplement Dates Manufacturer Received: 05/21/2024
• Supplement Dates FDA Received: 05/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/09/2014
• 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