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

Model Number 722012

Device Problems Bent (1059); Electrical /Electronic Property Problem (1198)

Patient Problem No Patient Involvement (2645)

Event Type  No Answer Provided  

Event Description

Philips received a complaint from a customer that the footswitch was not working.

Manufacturer Narrative

(b)(4).The field service engineer (fse)'s visual review of the system showed the footswitch was bent and not working properly.Philips conducted its investigation based on the info received.Based on available info, the cause could be related to the use of anti fatigue mats under the footswitches since the footswitch was designed to be used on a solid surface.After replacing the footswitch , the reported problem with the system was solved.Philips is working on adding a metal plate under the footswitch to prevent bending.

• Brand Name: ALLURA XPER FD20
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): PHILIPS HEALTHCARE; veenpluis 4-6; best 5680 DA; NL 5680 DA
• Manufacturer Contact: dusty leppert ; 3000 minuteman rd; andover, MA 01810 ; 9786597892
• MDR Report Key: 4722206
• MDR Text Key: 5743399
• Report Number: 3003768277-2015-00030
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K033737
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/23/2015

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: 03/23/2015
• Initial Date FDA Received: 04/20/2015
• 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