MAUDE Adverse Event Report: PHILIPS HEALTHCARE ALLURA XPER FD20 BIPLANE; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number 722013

Device Problems No Display/Image (1183); Defective Component (2292)

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

Event Type  malfunction  

Manufacturer Narrative

When the investigation has been completed philips will inform the fda.

Event Description

Philips has received through the food and drug administration medwatch program a voluntary event report submitted by (b)(6).In this report, it was reported: philips biplane equipment unable to produce fluoroscopic imaging due to defective cathode converter, resulting in the need to transfer the patient to alternative procedure suite.The event was reported by the customer as a product problem.Philips will start an investigation for this complaint.

Manufacturer Narrative

Philips has investigated this complaint.Philips has confirmed that fluoroscopy became unavailable during a cerebral angiogram under conscious sedation.The procedure was aborted and rescheduled.No patient or user harm has been reported.Philips inspected the system and confirmed that the system would not produce x-ray for the frontal plane.After troubleshooting the system and analyzing the generator logs, philips identified a defective cathode converter in the frontal generator which resulted in the inability to produce x-ray.The converter was replaced and the system was returned to use in good working order.Based on analysis of log files and system information, it cannot be determined what caused the converter to fail.There is no negative trend with the replacement rate for the converter.Consequently, philips has closed this complaint.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 FD20 BIPLANE
• 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: 9383588
• MDR Text Key: 175418898
• Report Number: 3003768277-2019-00098
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• PMA/PMN Number: K033737
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 722013
• Device Catalogue Number: 722013
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1