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

Model Number 722006

Device Problem Smoking (1585)

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

Event Type  malfunction  

Manufacturer Narrative

When the investigation is completed, a follow-up report will be sent to the fda.

Event Description

It was reported to philips that during a procedure smoke came out of the generator.No harm has been reported to philips.Philips has initiated an investigation of this complaint.

Manufacturer Narrative

Philips investigated this complaint.This system is not serviced by philips.On request for support on this case, philips provided diagnostic support to the customer¿s field service engineer.Based on the available information, it was concluded that the converter caused the smoke.The field service engineer of the customer replaced the converter after which the defective converter was scrapped.Because the converter is not available, philips cannot perform any further investigation.After the replacement, philips performed x-ray tube calibration adaptations and the system was in good working order.With regard to the procedure, it was completed successfully in another room.No further actions will be taken by philips.

Event Description

It was reported to philips that during a procedure smoke came out of the generator.No harm to the patient has been reported to philips.Philips has initiated an investigation of this complaint.

• Brand Name: ALLURA XPER FD20
• 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
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: dusty leppert ; veenpluis 4-6; p.o. box 10.000; best 5680 -DA ; NL 5680 DA
• MDR Report Key: 8802967
• MDR Text Key: 151560805
• Report Number: 3003768277-2019-00057
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K033737
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 722006
• Device Catalogue Number: 722006
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/18/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/15/2005
• 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