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

Model Number 722001

Device Problem Device Inoperable (1663)

Patient Problem Death (1802)

Event Date 09/01/2015

Event Type  Death  

Manufacturer Narrative

When investigation is completed a follow up report will be sent to fda.(b)(4).

Event Description

Philips received a complaint from a customer that geometry did not respond when they started the system for a cardiac catheterization procedure.They had to shut down the system to get it operating again.This caused a delay in the diagnosis of the patient.The procedure was completed.It was reported to philips that the patient died a few days later.

Manufacturer Narrative

Philips investigated this complaint and checked the log files of the day the problem occurred that were provided to the helpdesk for analysis.Research & development checked the logging and noted that the user interface driver was installed by a philips service engineer in the wrong way and that this caused the problems.Following the instructions from the helpdesk the philips field service engineer now installed the software correctly the geometry problem caused a delay in the cardiac catheterization procedure of 11.45 min.Clinical manager of the hospital stated that the incident of the patient expiring was not related to the failure of the system.The patient was in a very bad condition and expired shortly after the procedure (b)(4).

• Brand Name: ALLURA XPER FD10 C
• 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 Contact: dusty leppert ; veenpluis 4-6; p.o. box 10.000; best 5680 -DA ; NL 5680 DA
• MDR Report Key: 5090809
• MDR Text Key: 26271780
• Report Number: 3003768277-2015-00078
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K041949
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Followup
• Report Date: 09/11/2015

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: 722001
• Device Catalogue Number: 722001
• Device Lot Number: UNSURE
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/21/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/25/2016
• 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
• Patient Outcome(s): Death
• Patient Age: 30 YR