MAUDE Adverse Event Report: PHILIPS HEALTHCARE ALLURA XPER FD20

Model Number 722006

Device Problems Bent (1059); Device Inoperable (1663); Optical Problem (3001)

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

Event Type  malfunction  

Event Description

Philips received a complaint from a customer that the foot pedal was not functioning during the case.The relay light was on when the fluoroscopy was not working.The cause of the problem might be a bent footswitch.

Manufacturer Narrative

(b)(4).When investigation is completed, a follow up report will be sent to the fda.

• Brand Name: ALLURA XPER FD20
• Manufacturer (Section D): PHILIPS HEALTHCARE; veenpluis 4-6; best 5680 DA; NL 5680 DA
• Manufacturer Contact: dominic siewko ; 3000 minuteman rd.; ms 4-235; andover, MA 01810 ; 9786597936
• MDR Report Key: 3965953
• MDR Text Key: 4611624
• Report Number: 3003768277-2014-00068
• 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: 05/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 722006
• Device Catalogue Number: 722006
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/20/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1