MAUDE Adverse Event Report: PHILIPS HEALTHCARE ALLURA XPER FD10; SYSTEM, X-RAY, ANGIOGRAPHIC

Model Number 722010

Device Problem Bent (1059)

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

Event Type  malfunction  

Manufacturer Narrative

When the investigation has been completed philips will inform the fda.

Event Description

Philips received a complaint from the customer in which was stated that the customer experienced a problem with their footpedal while they tried to use fluoro.The footpedal for fluoro appeared to be bent.The customer reported that they were able to finish the procedure, and there were no ill effects for patient or staff.The particular procedure was not very fluoroscopy intensive, and they performed digital acquisitions (cine) to complete and document the procedure.

Manufacturer Narrative

Philips analyzed this complaint and came to the following conclusion.A philips field service engineer (fse) went to this site to test the operation of the foot switch and found that the fluoroscopy pedal was no longer operating correctly due to a mechanical failure.(bent pedal) although field change order (fco) (b)(4) had been implemented on this site the fse reported that there was no steel plate on the bottom of the faulty foot switch when he tested the operation of the foot switch.The former fse who had implemented the fco for this site, no longer works for philips.The local us philips organization investigated this and came to the conclusion that 100% of the other foot switch fco's dispatched to this former fse were completed correctly.Footpedal has been used on a mat, this has caused the bending of the foot pedal.The prior installed foot switch on site is believed to be removed either by the customer or third party as this system is not maintained by philips.All foot switch fco's have been implemented, therefore no corrections are necessary.

• Brand Name: ALLURA XPER FD10
• Type of Device: SYSTEM, X-RAY, ANGIOGRAPHIC
• Manufacturer (Section D): PHILIPS HEALTHCARE; veenpluis 4-6; p.o. box 10.000; best 5680 DA; NL 5680 DA
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: dusty leppert ; veenpluis 4-6; p.o. box 10.000; best 5680 -DA ; NL 5680 DA
• MDR Report Key: 6046305
• MDR Text Key: 58084098
• Report Number: 3003768277-2016-00101
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K041949
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/23/2016

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: 722010
• Device Catalogue Number: 722010
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/23/2016
• Initial Date FDA Received: 10/21/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/24/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1