MAUDE Adverse Event Report: PHILIPS HEALTHCARE ALLURA XPER FD20

Model Number 722006

Device Problem Bent (1059)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Philips received a complaint from a customer that the fluoroscopy pedal was bent and it disturbed the generation of live image during the case.

• Brand Name: ALLURA XPER FD20
• Manufacturer (Section D): PHILIPS HEALTHCARE; veenpluis 4-6; best 5680D A; NL 5680DA
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 4-6; best 5680D A; NL 5680DA
• Manufacturer Contact: deborah thurston ; 300 minuteman road; andover, MA 01810 ; 9786592010
• MDR Report Key: 5624479
• MDR Text Key: 44335650
• Report Number: 3003768277-2014-00124
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/02/2014

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: 722006
• Device Catalogue Number: 722006
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/02/2014
• Initial Date FDA Received: 10/29/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1