MAUDE Adverse Event Report: PHILIPS HEALTHCARE ALLURA XPER FD20; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number 722012

Device Problem Bent (1059)

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 switch was bent and therefore could not initiate a fluoroscopy exam.The procedure was terminated in a controlled manner without harm to the pt.

Manufacturer Narrative

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

• Brand Name: ALLURA XPER FD20
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): PHILIPS HEALTHCARE; veenpluis 4-6; best 5680D A; NL 5680DA
• Manufacturer Contact: deborah thurston ; 3000 minuteman rd; andover, MA 01810 ; 9786592010
• MDR Report Key: 4593760
• MDR Text Key: 5632226
• Report Number: 3003768277-2015-00022
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K033737
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 02/05/2015

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: 722012
• Device Catalogue Number: 722012
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/05/2015
• Initial Date FDA Received: 03/05/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1