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

Model Number 722010

Device Problems Device Displays Incorrect Message (2591); Radiation Overexposure (3017)

Patient Problem No Information (3190)

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 due to filter failure there was an overexposure of a patient.The customer states that it was 2.5 times the intended dose.The system gave an error message that there was a filter failure but the operator did not notice this message, another operator noticed this after the procedure was done.System was taken out of order.

Manufacturer Narrative

Philips investigated this complaint and came to the following conclusion: a philips remote service engineer looked into the log files and found that the problem was located in the filter area.A likely cause of problem: mechanical range check failed; collimator filter hardware or mechanics defect.A philips field service engineer (fse) confirmed the issue, replaced the faulty collimator and tested the system.The system is now functioning correctly.Replacement rates for this particular collimator (nicol v3 cv fd).2015: 3%.2016: 2%.2017: 3%.The philips upper control limit for this cllimator is: 5%.Although the patient received 2.5 times the intended dose, the cumulative air kerma was 443.48 mgy.No harm other than the increased dose was reported.Based on trending analysis there is no exceptional replacement rate for this item, therefore we take no further action in this matter.Conclusion of the analysis: collimator filter hardware or mechanics defect.The fse replaced the faulty collimator and tested the system.The system is now functioning correctly.The date the manufacturer was informed has been changed in to 13-jul-2017.

• 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: 6770132
• MDR Text Key: 82116715
• Report Number: 3003768277-2017-00070
• 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: 07/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Radiologic Technologist
• 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
• Date Manufacturer Received: 07/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/21/2013
• 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: 56 YR
• Patient Weight: 87