MAUDE Adverse Event Report: PHILIPS HEALTHCARE ALLURA XPER FD10 C

Model Number 722001

Device Problem Failure to Power Up (1476)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Philips received a complaint from a customer that during pacemaker implantation the system went down and customer could not power on the system anymore.They were able to finish the examination by using a backup system/.There was no patient harm.

Manufacturer Narrative

(b)(4).The field service engineer (fse) trouble shot the system found a problem with a defective power tray.He replaced the power tray, spare fuses, mpd (main power distribution) control unit and tested the system, this solved.

• Brand Name: ALLURA XPER FD10 C
• Manufacturer (Section D): PHILIPS HEALTHCARE; veenpluis 4-6; best 5680 ; NL 5680
• Manufacturer Contact: deborah thurston ; 3000 minuteman rd; andover, MA 01810 ; 9786592010
• MDR Report Key: 4322112
• MDR Text Key: 14878954
• Report Number: 3003768277-2014-00130
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K031333
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/08/2014

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: 722001
• Device Catalogue Number: 722001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/08/2014
• Initial Date FDA Received: 12/03/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1