MAUDE Adverse Event Report: PHILIPS HEALTHCARE ALLURA XPER FD10/10

Model Number 722005

Device Problems Device Operates Differently Than Expected (2913); Power Problem (3010)

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

Event Type  malfunction  

Event Description

Philips received a report from a customer that the x-ray stopped and x-ray lamp comes on and flashed.This malfunction is related to the failure of power tray.

Manufacturer Narrative

(b)(4).When investigation is completed a f/u report will be sent to the fda.

• Brand Name: ALLURA XPER FD10/10
• Manufacturer (Section D): PHILIPS HEALTHCARE; veenpluis 4-6; best 5680 DA; NL 5680DA
• Manufacturer (Section G): PHILIPS HEALTHCARE - IMAGING SYSTEMS; 3000 minuteman rd; ms 4-135; andover MA 01810
• Manufacturer Contact: dominic siewko ; veenpluis 4-6; best 5680 ; NL 5680 ; 9786597936
• MDR Report Key: 3750525
• MDR Text Key: 18734043
• Report Number: 3003768277-2014-00008
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031333
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 722005
• Device Catalogue Number: 722005
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/13/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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