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

Model Number 722012

Device Problem Computer Operating System Problem (2898)

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

Philips has received through the food and drug administration medwatch program a voluntary event report submitted by chandler regional medical center (report number mw (b)(4)).In this report, it was reported: cath lab (cardiac catheterization lab) would not boot up at start of the day.Failure of the ippc (image processing pc).This device has failed or.12/12/19 and 2/5/20 as well.Manufacturer: can only replace the part, which then fails, and then several months later it fails again.This time there was not a patient on the table yet.Philips has started an investigation for this complaint.

Manufacturer Narrative

Philips has investigated this complaint.Philips has inspected the system on site and it was identified that the ip-pc (image processing pc) failed.Analysis of the log files has also confirmed the failure of the ip pc.The defective ip-pc was replaced and the system was returned to use in good working order.Based on trending analysis there is no negative trend in the replacement rate for the ip-pc.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
• 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: 10086826
• MDR Text Key: 192465732
• Report Number: 3003768277-2020-00028
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• PMA/PMN Number: K130638
• 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: 05/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 722012
• Device Catalogue Number: 722012
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1