MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALLURA XPER FD10; SYSTEM, X RAY SYSTEM, ANGIOGRAPHIC

Model Number 722003

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 fluroscopy failed during the study due to a bent footswitch.

Manufacturer Narrative

(b)(4).Philips received a complaint from a customer that the fluoroscopy failed during the study due to a bent footswitch.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 information received.Based on available information, 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 adjustment of 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 FD10
• Type of Device: SYSTEM, X RAY SYSTEM, ANGIOGRAPHIC
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 4-6; best 5680 DA; NL 5680 DA
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 4-6; best 5680 DA; NL 5680 DA
• Manufacturer Contact: deborah thurston ; 3000 minuteman rd; andover, MA 01810 ; 9786592010
• MDR Report Key: 4355787
• MDR Text Key: 5222445
• Report Number: 3003768277-2014-00134
• 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: Health Professional
• Type of Report: Initial
• Report Date: 10/21/2014

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: Other
• Device Model Number: 722003
• Device Catalogue Number: 722003
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/21/2014
• Initial Date FDA Received: 12/17/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1