MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALLURA FC; SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED

Model Number ALLURA FC

Device Problem Smoking (1585)

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

Event Date 04/25/2022

Event Type  malfunction  

Event Description

It has been reported to philips that smoke was coming out from x-ray generator.The system was not in clinical use.No harm has been reported to philips.Philips has started an investigation of the complaint.

Manufacturer Narrative

According to the additional information collected, the smoke stopped automatically after 15-20 minutes.A philips service engineer inspected the system onsite.Visual inspection of the x-ray generator did not show any burning spots.The reported problem could not be confirmed by the engineer.Corrected data: due to technical constraints we were unable to fill the correct manufacturing site.The correct manufacturing site should be: philips india ltd.Plot no.B-79, midc, phase-ii, chakan pune 410501.India.

• Brand Name: ALLURA FC
• Type of Device: SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 4-6; best 5684 PC; NL 5684 PC
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 4-6; best 5684 PC; NL 5684 PC
• Manufacturer Contact: dusty leppert ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 14461772
• MDR Text Key: 300342115
• Report Number: 3010685285-2022-00001
• Device Sequence Number: 1
• Product Code: JAA
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K022899
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,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 FC
• Device Catalogue Number: 723003
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/25/2022
• Initial Date FDA Received: 05/20/2022
• Supplement Dates Manufacturer Received: 04/25/2022
• Supplement Dates FDA Received: 08/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/20/2005
• 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