MAUDE Adverse Event Report: PHILIPS HEALTHCARE ALLURA XPER FD10; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number 722010

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The investigation is still ongoing for this event.When the investigation is completed a follow-up will be sent to the fda.

Event Description

It has been reported to philips that during the start of an emergency coronary angiography (cag), a warning message appeared on the live monitor shortly after switching on the system that exposure was not possible.There was a delay of 10 - 12 minutes before the system was restarted and exposure was available.No patient harm has been reported to philips.Philips has started an investigation for this complaint.

Manufacturer Narrative

Philips has investigated this complaint.Philips has confirmed with the customer that exposure was available again after the system was restarted two times.The cag procedure was completed successfully with a delay of 10 to 12 minutes.Philips has confirmed that the issue did not recur after the restarts.Philips has completed a good faith effort to get further information regarding the patient and procedure.However, this was not provided due to privacy reasons.Philips has inspected the system on site and based on troubleshooting identified a failure of the flat detector (fd) controller may likely have led to the reported issue.The fd controller was replaced proactively based on troubleshooting.The system was checked and returned to use in good working order.Analysis of the log files identified a connection error with the fd controller.However, the exact cause of the connection error could not be determined.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

• Brand Name: ALLURA XPER FD10
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): PHILIPS HEALTHCARE; veenpluis 4-6; p.o. box 10.000; best 5680 DA; NL 5680 DA
• MDR Report Key: 10287726
• MDR Text Key: 199840360
• Report Number: 3003768277-2020-00039
• Device Sequence Number: 1
• Product Code: OWB
• UDI-Device Identifier: 00884838059030
• UDI-Public: (01)00884838059030
• Combination Product (y/n): N
• PMA/PMN Number: K130638
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 722010
• Device Catalogue Number: 722010
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1