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

Model Number 722010

Device Problem Radiation Overexposure (3017)

Patient Problem Burn(s) (1757)

Event Date 06/30/2017

Event Type  Injury  

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 the large amount of skin dose radiation received during a cath-lab ptca procedure, the patient was suffering of a burned skin.

Manufacturer Narrative

A philips field service engineer went onsite on the (b)(6) 2017.The fse confirmed that all tests performed on the (b)(6) 2017 (latest service event on the system) showed that the system was working within specification.The fse checked and performed testing on the system again on the (b)(6) 2017, and no problem was found.The system was working within specification and no correction was needed.A philips system designer analyzed the information received.Through the dose report it was confirmed that patient received a dose of 11,5 gy during a long examination (2,5 hours) with a total of 118 cine runs and almost 45 minutes of fluoroscopy.This high dose is considered to be the cause of the patient burn since the stand position was hardly changed during the whole procedure and all radiation entered the skin at the same spot.The average object thickness was 37 cm which requires high power to produce acceptable images, but will also lead to a higher dose.There is no indication in the log files of any malfunctioning of the system that could have contributed to the total air kerma received by the patient.The total air kerma received by the patient is as expected considering the setting chosen by the customer and the complexity of the procedure.Since there is no system malfunction no further action will be taken in this matter.

• 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: 6830931
• MDR Text Key: 83988591
• Report Number: 3003768277-2017-00077
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 08/25/2017

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?: No
• Device Operator: No Information
• 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
• Initial Date Manufacturer Received: 08/21/2017
• Initial Date FDA Received: 08/30/2017
• Supplement Dates Manufacturer Received: 08/21/2017
• Supplement Dates FDA Received: 12/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/29/2011
• 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 Age: 35 YR
• Patient Weight: 124