MAUDE Adverse Event Report: PHILIPS HEALTHCARE ALLURA XPER FD SERIES / ALLURA XPER OR TABLE SERIES; ANGIOGRAPHIC X-RAY SYSTEM, SOLID X-RAY IMAGER

Model Number 722029

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Injury did not occur but there are potential unpredictable consequences if the acquisition stops during embolization phase when the investigation has been completed philips will inform the fda (b)(4).

Event Description

Philips received a complaint from the customer in which was stated that they noticed an unjustified interruption of image acquisition during embolization exam.Momentary indication of tube overload signal, without any indication of tube load level.The procedure was finished without complications for the patient.

Manufacturer Narrative

Philips investigated this complaint, by reviewing the logfile it became clear that when the doctor is preparing his procedure settings the phase 2 duration is set to 0 seconds.In case the phase 2 duration = 0 the phase 1 becomes infinite by design.But the max power calculation still takes the phase_1 duration into account.This means that the tube will become overheated if it is used longer than the phase_1 duration, which is possible if the user doesn¿t release the exposure pedal the provided log files have been analyzed by our product designer.And it was found that the tube became overheated due to the programmed sequences and to the exposure pedal not being released.The programmed sequences consist of three phases.The programmed sequences phases were: 4 seconds 3 fps (frames per second), 0 seconds 2 fps and 5 seconds 1 fps.The maximum pulse power is calculated for the programmed sequence.In case the phase 2 duration is 0, the phase 1 becomes infinite.This means that the tube will become overheated if it is used longer than the phase 1 duration and the exposure pedal is not released.The tube overheating can be avoided by programming a longer phase 1 duration time or as required in this case by defining a phase 2 duration.The product designer advises to have an application specialist of philips on site to discuss this finding as well as possible improvements to the work-flow, where needed.The customer can adjust the programmed sequence phases.The system did not malfunction the settings were changed whereby the tube can get overloaded when the signs are ignored.The application specialist has gone on site and made the following adjustments: set all three phases to the same frame rate.Lengthened the run durations for all three phases to 8 seconds.Lowered power factor for 3, 4, and 6 fps programs.

• Brand Name: ALLURA XPER FD SERIES / ALLURA XPER OR TABLE SERIES
• Type of Device: ANGIOGRAPHIC X-RAY SYSTEM, SOLID X-RAY IMAGER
• 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: 6025482
• MDR Text Key: 57271309
• Report Number: 3003768277-2016-00097
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• Reporter Country Code: GR
• PMA/PMN Number: K141979
• 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: 09/15/2016

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: 722029
• Device Catalogue Number: 722029
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/15/2016
• Initial Date FDA Received: 10/13/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/11/2015
• 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