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

Model Number 722010

Device Problem Failure to Auto Stop (2938)

Patient Problem Overdose (1988)

Event Type  malfunction  

Manufacturer Narrative

When the investigation has been completed philips will inform the fda.

Event Description

Philips received a complaint from the customer in which it was stated that the user was screening and took his foot of the pedal, the system continued screening and the user had to use the emergency stop to stop the screening.Therefore the patient received additional dose.

Manufacturer Narrative

Philips investigated this complaint and came to the following conclusion: the logfiles are no longer available, therefore we are unable to further investigate this issue.However, based on the symptoms, it is very likely that the issue is caused by the ¿10 seconds issue¿.This is a known issue.The occurrence per system ranges from 3-4 times per month to once every 1-2 months.The ¿10 seconds issue¿ may occur intermittently.The design of the system ensures that when the footswitch is released, the enable_x-ray line is made inactive, the x-ray is stopped immediately (or at least within 400 ms.).This is the case even if the handling of the x-ray stop in software is suffering a delay, causing also the x-ray indicators to be switched off some time after the footswitch has been released.In this specific situation the patient has had no extra dose, although it may look like this for the clinical user as the delayed prepare off keeps all visible and audible xray indicators alive.Conclusion of the analysis: the cause of the issue was not identified.As a preventive measure the system interface board box was replaced.However, based on the symptoms, it is very likely that the issue was caused by the 10 seconds issue.This is a structural issue.Philips is planning to solve this problem according the appropriate processes and will inform all stakeholders via regular channels.

• 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: 6507620
• MDR Text Key: 73495361
• Report Number: 3003768277-2017-00042
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 04/10/2017

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: 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: 04/10/2017
• Initial Date FDA Received: 04/20/2017
• Supplement Dates Manufacturer Received: 04/10/2017
• Supplement Dates FDA Received: 09/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2010
• 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 Age: 72 YR