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

Model Number AZURION 5 M12

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 01/12/2024

Event Type  malfunction  

Event Description

It was reported to philips that the cover fell off the device during an examination.Issue occurred during clinical use.No patient or user harm was reported.Philips has started an investigation of this complaint.

Manufacturer Narrative

Philips has investigated this complaint.According to additional information, the procedure was completed by attaching the cover temporarily with an adhesive tape.There was no harm to the patient.The customer connected with philips remote service engineer (rse) , and it was reported that the cover fell off during examination.Review of system log file could not confirm the malfunction.The philips engineer has advised to act at their own risk to the customer until the replacement.The replacement for the damaged cover has been performed in another work order.After which, the system was returned to use in good working order.The codes were updated based on the investigation outcome.Evaluation method code was corrected.

• 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: 18592669
• MDR Text Key: 333903896
• Report Number: 3003768277-2024-00498
• Device Sequence Number: 1
• Product Code: OWB
• UDI-Device Identifier: 00884838099227
• UDI-Public: 00884838099227
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AZURION 5 M12
• Device Catalogue Number: 722227
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/12/2024
• Date Device Manufactured: 03/24/2021
• 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