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

Model Number 722026

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Philips was informed that during a procedure for a percutaneous coronary intervention, the user noticed that the system gave a signal that the system was generating x-ray after the footswitch was released.The user decided to stop the system by using the emergency button.After a restart the system did not function anymore, this led to a situation where the user had to deflate and remove the balloon without image.According to the customer this could have led to a cardiac arrest.The patient was moved to another cathlab where the procedure was finished.

Manufacturer Narrative

Philips investigated this issue.The host pc of the system was defective.Replacing the host pc solved the issue reported.The replaced host pc was evaluated and it was found out that the disk bay of the host pc was defective.Because of this the system was unable to turn off the x-ray buzzer or respond to any commands during the clinical procedure.The design of the allura system ensures that when the footswitch is released, the x-ray is stopped within 400ms maximum.This is the case even if the handling of the x-ray stop in software is having any delay.Because the defective disk bay of the host pc, the system did not restart.Search in the complaints database has not shown similar cases.Analysis of replacement rate for the host pc did not show any negative trend.No further action will be taken.

• 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: 7288970
• MDR Text Key: 100787625
• Report Number: 3003768277-2018-00015
• Device Sequence Number: 1
• Product Code: IZI
• UDI-Device Identifier: 00884838054189
• UDI-Public: (01)00884838054189
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K031333
• 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: 01/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 722026
• Device Catalogue Number: 722026
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/09/2017
• 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: 59 YR