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

Model Number 722003

Device Problem Radiation Overexposure (3017)

Patient Problem Radiation Exposure, Unintended (3164)

Event Type  malfunction  

Manufacturer Narrative

When the investigation has been completed philips will inform the fda as for the error logs, there was no error because the examination programmed x-ray (epx) database was programmed to 15frames per second, but the description of the epx was either 3.75fps or 7.5fps.

Event Description

Philips received a complaint from the customer that on (b)(6) 2017 they were having problems selecting examination left coronary on xper module, if they select left coronary 3.25f/s or left coronary 7.5f/s the system uses 15f/s.As a result the patient received 1.041 gy of unnecessary radiation.No patient harm was reported by the customer.

Manufacturer Narrative

A philips system designer analyzed the log files and dose information provided and concluded that there was 1.041 gy accidental radiation.This additional dose occurred because the epx (examination, patient type and x-ray operator setting) database was programmed to 15 frames per second (fps), but the description of the epx showed either 3.75fps or 7.5fps.This epx database must have been reset to factory settings during the implementation of an fco.According to the customer, these settings have never been used before this incident, so as far as they are concerned this is the only incident.The name of the epx on the display of the table side monitor (tsm) is not linked to the epx setting and can be changed.Using the framerate in the epx name is a customer preference.On the monitor, the user can always see the actual framerate during the procedure, so in case of mismatch between the actual framerate and that shown in the epx name, the mismatch could be noticed by the user.Currently, fco instructions for execution include specific instructions on actions with customer databases.This should prevent to overwrite the customer specific settings.The field service engineer (fse) reconfigured the epx settings, which solved the issue reported by the customer.

• 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: 6763383
• MDR Text Key: 81703208
• Report Number: 3003768277-2017-00069
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 07/26/2017

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: 07/26/2017
• Initial Date FDA Received: 08/03/2017
• Supplement Dates Manufacturer Received: 07/26/2017
• Supplement Dates FDA Received: 12/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/06/2006
• 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: 84 YR