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

Model Number 722003

Device Problem Failure to Power Up (1476)

Patient Problem No Code Available (3191)

Event Type  malfunction  

Manufacturer Narrative

Philips will analyze the logfiles when they are available.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 when an emergency patient with an infarction needed an exam on the system, the system did not start up.The patient was transferred to another hospital.Philips was not informed about the patient outcome.

Manufacturer Narrative

Philip investigated this complaint and came to the following conclusion: the field service engineer (fse) troubleshot the system on the (b)(6) 2017 and found that the system would not start, the system resumes its cycle endlessly.He tried to access the service mode but was unable to do so, he then reverted the system to a backup of the (b)(6) 2017 and solved the issue by doing so.The fse did not have logfiles available to be analyzed after this event.Based on the symptoms our subject matter expert indicated on the 6th of september 2017 that the most likely cause was that some necessary files on the operating system (os)-disk were corrupted and prevented the system from starting.He also indicated that since they restored a backup to the original os-disk, the loggings from that moment are gone forever.Philips advised the fse to replace the os-disk of the system.Conclusion of the analysis: based on trending analysis there is no exceptional replacement rate for this item, therefore we take no further action in this matter.

• 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: 6533825
• MDR Text Key: 74255540
• Report Number: 3003768277-2017-00044
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 04/09/2017

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: 722003
• Device Catalogue Number: 722003
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/09/2017
• Initial Date FDA Received: 05/01/2017
• Supplement Dates Manufacturer Received: 04/08/2017
• Supplement Dates FDA Received: 09/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/18/2009
• 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