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

Model Number 722003

Device Problem Defective Component (2292)

Patient Problem No Code Available (3191)

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 it was stated that one of the front teeth of the patient was hit by the flat detector because the flat detector shift potmeter was defective.One of the front tooth of the patient became loose.Philips has not been informed if the patient needed any treatment for this loose tooth.

Manufacturer Narrative

Philips investigated this complaint and came to the following conclusion: on 2017mar28 a philips field service engineer (fse) went on site and found that the potentiometer did not give a constant value and had one position where it skipped a value whereby the flat detector hit the patient teeth.The logfiles were checked but no errors found.The fse replaced the potentiometer and the system was working according specifications after replacement.No structural defect could be identified as no similar issue were found in the past.

• 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: 6463239
• MDR Text Key: 72185093
• Report Number: 3003768277-2017-00037
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K041949
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/28/2017

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: 722003
• Device Catalogue Number: 722003
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/28/2017
• Initial Date FDA Received: 04/06/2017
• Supplement Dates Manufacturer Received: 03/28/2017
• Supplement Dates FDA Received: 08/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/29/2006
• 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
• Patient Age: 76 YR
• Patient Weight: 86