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

Model Number AZURION 7 M12

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 02/06/2024

Event Type  malfunction  

Event Description

It has been reported to philips that there was a structural issue and that one of the support beams was damaged.The system was in clinical use at the time of the event.No harm was reported to philips.Philips has started an investigation of this complaint.

Manufacturer Narrative

Philips has investigated this complaint.According to additional information collected, the system was in clinical use when the issue was identified, and the procedure was aborted and completed after moving the patient to another room.No patient harm was reported.A philips field service engineer (fse) examined the system onsite and confirmed that the structural issue - one of the support beams has collided and is damaged.Upon functional testing fse found that the cause of the issue was due to the lead shield and light not being in the correct place.So, when the radiographer moved the beam, it collided with the lead shield.To resolve the issue fse replaced the beam.After the replacement, the system returned to use in good working order.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: 18721514
• MDR Text Key: 335596143
• Report Number: 3003768277-2024-00988
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K172822
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AZURION 7 M12
• Device Catalogue Number: 722078
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/06/2024
• 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