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

Model Number 722003

Device Problem Insufficient Information (3190)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 04/07/2017

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 a patient received 6.795 gy during a procedure.The customer used 19 minutes of fluoro and 34 sequences 963 images.

Manufacturer Narrative

Philips investigated this complaint and came to the following conclusion: the dose values with pre filter (0.1 cu + 1.0 mm al) were 10 times too high.During the last tube yield calibration the philips field service engineer has incorrectly entered the measured values.As a result the dose values with pre filter (0.1 cu + 1.0 mm al) were 10 times too high.So the patient did not receive a high dose, but 10 times less as indicated in the initial report.Therefore we do not consider this as a serious injury.The field service engineer could correct this issue and the tube yield and edl calibration are now correct on this system.A formal communication has been sent out to inform the philips field service engineers in france in order to inform them about this problem.

• 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: 6499561
• MDR Text Key: 73019639
• Report Number: 3003768277-2017-00040
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 04/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 04/10/2017
• Initial Date FDA Received: 04/18/2017
• Supplement Dates Manufacturer Received: 04/10/2017
• Supplement Dates FDA Received: 08/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/06/2009
• 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 Outcome(s): Other
• Patient Weight: 73