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

Model Number AZURION 7 B12

Device Problems Shielding Failure (1568); Detachment of Device or Device Component (2907)

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

Event Date 05/10/2023

Event Type  malfunction  

Event Description

It has been reported to philips that the joint cover of the ceiling radiation shield has dropped on the azurion 7 b12 system.It was later indicated that the cover dropped don the patient table, but that this occurred before a patient examination and that the customer had to replace the clean sheets on the table as a result.No harm was reported to philips.Philips has started an investigation of the complaint.

Manufacturer Narrative

Philips has investigated this complaint.According to the additional information collected the system was not in clinical use.The philips field service engineer (fse) inspected the system onsite and confirmed the reported problem.Up on visual inspection fse found signs that the dislodged cover had collided with something which leads to fall of the ceiling cover.Technical investigation also confirmed the issue was due to external collisions.The fse re-installed the cover back to its position.After this, the device was returned to use in good working order.

• 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: dusty leppert ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 16952863
• MDR Text Key: 315866706
• Report Number: 3003768277-2023-02896
• Device Sequence Number: 1
• Product Code: OWB
• UDI-Device Identifier: 00884838085350
• UDI-Public: 00884838085350
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AZURION 7 B12
• Device Catalogue Number: 722067
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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