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 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 has received through the danish medicines agency a report (dkma ref.: (b)(4)) submitted by a customer.In this report the customer reported: ¿acute primary patient with an embolism in the heart is located on the table in room 5.We have started the procedure.During the procedure, before we have entered the wire into the vessel, then the x-ray equipment will not rotate around the patient.The system is then re-booted/a cold shot down and hereafter the system is working again¿.Philips has initiated an investigation of this complaint.

Manufacturer Narrative

Philips investigated this complaint.Philips troubleshooted the system and replaced the motor for c-arc rotation.Thereafter, no reoccurrence has been reported to philips.Investigation included a verification of the log files of the complaint which found that a warm restart was logged but no error was identified related to the c-arc rotation.No similar complaints have been identified.No further actions will be taken.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: 8189060
• MDR Text Key: 131337447
• Report Number: 3003768277-2018-00099
• 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: 12/06/2018

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
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/06/2018
• Initial Date FDA Received: 12/21/2018
• Supplement Dates Manufacturer Received: 12/06/2018
• Supplement Dates FDA Received: 02/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1