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

Model Number 722010

Device Problem Computer Operating System Problem (2898)

Patient Problem No Information (3190)

Event Date 07/25/2017

Event Type  Injury  

Manufacturer Narrative

Philips is in the process of obtaining additional information.When the investigation has been completed philips will inform the fda.

Event Description

Philips received a complaint where it was reported that during a percutaneous coronary intervention on the (b)(6), the system needed to be restarted.This restart caused a delay of 15 minutes during the procedure.

Manufacturer Narrative

Philips investigated this complaint.The analysis of the logfiles did not show any malfunction or system hiccup that would explain why a cold restart was required during the procedure.The cold restart took 10 minutes instead of 6 minutes.The increased shutdown time was due to the main power distribution unit (mpdu) requiring a 7 minutes time-out.In systems with a mpdu and physio-signals connected the system interface board-box, the shutdown of the mpdu may take up to 7 minutes resulting in a longer shutdown of the system.The physio-signals system has been disconnected to solve the issue.Philips has not been reported that the delay in treatment resulted in any complication for the patient or that it resulted in a prolonged stay of the patient in the hospital.

• 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
• 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: 6985972
• MDR Text Key: 90535640
• Report Number: 3003768277-2017-00092
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K041949
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 722010
• Device Catalogue Number: 722010
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/25/2017
• Initial Date FDA Received: 10/27/2017
• Supplement Dates Manufacturer Received: 10/25/2017
• Supplement Dates FDA Received: 02/14/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2010
• 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
• Patient Outcome(s): Hospitalization
• Patient Age: 81 YR
• Patient Weight: 60