MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALLURA XPER FD20/10 & ALLURA XPER FD20/20; SYSTEM, X-RAY, ANGIOGRAPHIC

Model Number 722008

Device Problem Radiation Overexposure (3017)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 10/07/2020

Event Type  malfunction  

Event Description

It has been reported to philips that during a general surgery procedure the patient received a high amount of radiation.No patient harm has been reported.Philips has started an investigation for this complaint.

Event Description

Philip has investigated this complaint.Philips confirmed that the patient received 5.5 gy during a complex emergency procedure.The procedure was completed successfully.No patient harm has been reported.Philips inspected and tested the system onsite.The system is working as designed and the dose produced is within specification.No malfunction was found.Based on the information collected and investigation performed, the high dose was caused by the high number of images taken during the procedure and the dose settings chosen by the customer.The customer has been educated on dose reduction techniques.The instructions for use provide radiation guidelines to reduce dose (4522 203 17232 chapter 2.9).Philips concludes that the high dose received by the patient is not a result of any issue with the system.

• Brand Name: ALLURA XPER FD20/10 & ALLURA XPER FD20/20
• Type of Device: SYSTEM, X-RAY, ANGIOGRAPHIC
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 4-6; best 5684 PC; NL 5684 PC
• MDR Report Key: 10716454
• MDR Text Key: 212469197
• Report Number: 3003768277-2020-01013
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• PMA/PMN Number: K130842
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup

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?: No
• Device Operator: Health Professional
• Device Model Number: 722008
• Device Catalogue Number: 722008
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 10/07/2020
• Initial Date Manufacturer Received: 10/07/2020
• Initial Date FDA Received: 10/22/2020
• Supplement Dates Manufacturer Received: 10/07/2020
• Supplement Dates FDA Received: 03/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Weight: 83