MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. AZURION; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number AZURION 7 M20

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/02/2024

Event Type  malfunction  

Event Description

It was reported to philips that the radiation shield arm cover falls.No harm to the patient or user was reported.Philips has started an investigation of this complaint.

Manufacturer Narrative

Philips has investigated the reported problem.According to the additional information collected, the system was not in clinical use when the issue occurred.It is not known how the radiation shield arm covers fell off as the customer found the covers lying on the floor.A philips field service engineer (fse) inspected the radiation shield arm onsite and confirmed that the radiation shield arm covers were not broken, and no signs of damage was found.The fse solved the issue by remounting the radiation shield arm covers and the correct working of the radiation shield arm was checked.The system was returned to use in good working order.The ceiling mounted shield is a third party manufactured component that may be used with the azurion system.The ceiling mounted radiation shield is typically suspended next to the patient and in front or next to the user.During the procedure to protect the user from scatter radiation.If the ceiling mounted radiation shield or parts should fall during a procedure, it is likely to immediately disrupt the procedure and or lead to abortion of the procedure.Per the ifu, if desired, the ceiling radiation shield [the user may] place a sterile bag over the apron of the shield and part of the lead acrylic shield, securing the bag in the two notches.However, if no sterile cover is used, there is the potential for the shield and or unsterile components (e.G., elbow covers) to fall and compromise the sterility of the surgical field.The chance of a death or serious injury occurring as a result of a recurrence of this scenario is not remote.The codes were updated based on the investigation outcome.

• Brand Name: AZURION
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer Contact: derrick massuri ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 18530854
• MDR Text Key: 333144008
• Report Number: 3003768277-2024-00245
• Device Sequence Number: 1
• Product Code: OWB
• UDI-Device Identifier: 00884838099258
• UDI-Public: 00884838099258
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K200917
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AZURION 7 M20
• Device Catalogue Number: 722224
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/15/2022
• 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