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

Model Number ALLURA XPER FD20

Device Problem Smoking (1585)

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

Event Date 03/16/2023

Event Type  malfunction  

Event Description

It has been reported that smoke was coming from the e-cabinet (generator cabinet).The system was not in clinical use, no harm has been reported to philips.The fire departement came onsite.Philips inspected the system onsite and identified that oil leaked from the chiller and leaked into the cabinet including the electronics.This resulted in smoke in the room.

Manufacturer Narrative

Philips has investigated this complaint.The philips field service engineer (fse) inspected the system onsite and confirmed that there was smoke and a burning smell in the lab coming from the e-cabinet.During troubleshooting, the fse identified that oil from the cooling unit leaked and sprayed the entire cabinet including electronics and the cause of the issue was e-cabinet.Fse replace the e-cabinet.After replacing e-cabinet, 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: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• 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: dusty leppert ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 16732161
• MDR Text Key: 313214629
• Report Number: 3003768277-2023-02286
• Device Sequence Number: 1
• Product Code: OWB
• UDI-Device Identifier: 00884838054202
• UDI-Public: 00884838054202
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162859
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: 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

• Date FDA Received: 04/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ALLURA XPER FD20
• Device Catalogue Number: 722028
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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