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

Model Number 722003

Device Problem Unexpected Shutdown (4019)

Patient Problem No Code Available (3191)

Event Date 06/03/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Philips has been reported that during a right subclavian angioplasty procedure the system stopped.The stent was positioned in an unknown location.The patient had to undergo an additional procedure.Philips has initiated an investigation of this complaint.

Manufacturer Narrative

Philips has investigated this complaint.On the 3rd of june 2019 the customer experienced that no x-ray was available during clinical use.The customer rebooted the system.After the system reboot x-ray was available again , however the geometry movements were not possible.The customer identified problems with the footswitch causing the x-ray to be unavailable.A deformed pedal with the original installed footswitch 989601040072 is not considered a structural issue as it is not an affected item in earlier issued field change orders 72200248.Philips recommended the customer to replace the footswitch.The customer did did not want to replace it and repaired the footswitch locally.This solved the reported issue regarding the no x-rays available.Regarding the unavailability of the geometry, philips analyzed the log file and confirmed that there was a problem with the geo ipc.Due to the malfunction of the geo ipc, the emergency stop is activated (safety feature).This caused the table to float and the geometry to be deactivated.After the geometry pc was replaced, the system was returned in good working order.Based on trending analysis there is no exceptional replacement rate for the geometry pc and the footswitch.The customer confirmed that the patient did not sustain any harm, therefore philips changed the type of this report from serious injury to malfunction.No similar complaints have been identified.No further actions will be taken by philips.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 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
• MDR Report Key: 8678083
• MDR Text Key: 147302667
• Report Number: 3003768277-2019-00048
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• PMA/PMN Number: K041949
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/04/2019

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: 722003
• Device Catalogue Number: 722003
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/04/2019
• Initial Date FDA Received: 06/07/2019
• Supplement Dates Manufacturer Received: 06/04/2019
• Supplement Dates FDA Received: 09/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 31 YR
• Patient Weight: 44