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

Model Number 722026

Device Problem Radiation Overexposure (3017)

Patient Problem Radiation Overdose (1510)

Event Type  malfunction  

Manufacturer Narrative

When the investigation has been completed philips will inform the fda.

Event Description

It has been reported to philips that during a puncture procedure the customer noticed that the patient received a high dose.No harm to the patient or user was reported.Philips has started an investigation of this complaint.

Manufacturer Narrative

Philips has investigated this complaint.Philips has confirmed that the reported issue occurred during a coronary emergency procedure, which was completed successfully, without delay.The customer reported that the large focus of the tube was defective (user message received: ¿warning: small focus used.Large focus defect¿).The procedure was completed with small focus.Additionally, the customer reported higher than expected dose compared to similar procedures.Based on the dose report provided by the customer, the patient received 2.03 gy.Philips analyzed the system onsite and confirmed the large focus defect.The x-ray tube was replaced, which solved the large focus defect.The system was returned to use in good working order with no reoccurrence of the issue.The focal spot is the region of the x-ray tube from which the x-rays emanate.The focal size determines the sharpness of x-ray images.X-ray tubes have two different foci, the large and small focus.The x-rays system is designed such that when the large focus is defect, the system will automatically switch to small focus.The selected focus size does not have impact on the dose output of the system, but there is a possibility of reduced image quality.In case of reduced image quality, the customer may decide to switch to a higher dose setting.The customer did not report reduced image quality or a switch to a higher dose settings during the procedure.Analysis of the log files confirmed that there was a high number of images (6000 images) made during the procedure, which correspond to the reported dose of 2.03 gy.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

• 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
• MDR Report Key: 10527046
• MDR Text Key: 207748460
• Report Number: 3003768277-2020-00059
• Device Sequence Number: 1
• Product Code: IZI
• UDI-Device Identifier: 00884838054189
• UDI-Public: (01)00884838054189
• Combination Product (y/n): N
• PMA/PMN Number: K031333
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/21/2020

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: 722026
• Device Catalogue Number: 722026
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/09/2020
• Initial Date FDA Received: 09/14/2020
• Supplement Dates Manufacturer Received: 08/21/2020
• Supplement Dates FDA Received: 02/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 80