MAUDE Adverse Event Report: PHILIPS HEALTHCARE ALLURA XPER FD10; SYSTEM, X-RAY, ANGIOGRAPHIC

Model Number 722003

Device Problems No Display/Image (1183); Fire (1245); Smoking (1585)

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 was reported to philips that after completion of a procedure, while the patient was waiting to leave the exam room, the system monitors went blank.After unsuccessfully attempting to restart the system, the customer went to the control room and discovered smoke coming from the cabinet of the x-ray system.The fire department was notified and the fire was extinguished.No patient or user harm has been reported to philips.

Manufacturer Narrative

Philips has investigated this complaint.Philips has inspected the system on site and confirmed that the power supply cables were damaged due to a leak in the detector cooling system, which caused cooling liquid to leak out and drip onto the cables in the r-cabinet.A field safety notice was issued on 09 march 2017 to inform customers of potential system damage due to leakage of coolant liquid from the detector cooling system.According to service records, the related field safety corrective action (fco72200384 (2016-igtbst-002)) was implemented on this system on 18 april 2018 to install the extended drip tray, which prevents cooling liquid from leaking outside of the drip tray of the detector cooling system (chiller).Inspection of the system after this incident identified that the extended drip tray was missing.The damaged cables were replaced and an extended drip tray was installed, after which the system was returned to use in good working order.Philips has not been able to determine the exact cause of the missing extended drip tray.No similar complaints related to this fco were found.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 FD10
• Type of Device: SYSTEM, X-RAY, ANGIOGRAPHIC
• Manufacturer (Section D): PHILIPS HEALTHCARE; veenpluis 4-6; p.o. box 10.000; best 5680 DA; NL 5680 DA
• MDR Report Key: 9610828
• MDR Text Key: 180312011
• Report Number: 3003768277-2020-00006
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• PMA/PMN Number: K041949
• 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: 01/09/2020

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: 722003
• Device Catalogue Number: 722003
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/09/2020
• Initial Date FDA Received: 01/21/2020
• Supplement Dates Manufacturer Received: 01/09/2020
• Supplement Dates FDA Received: 05/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1