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 04/13/2022

Event Type  malfunction  

Event Description

It has been reported to philips that during a procedure the l-arm rotation cover became detached.No harm has been reported to philips.Philips has started an investigation of this complaint.

Manufacturer Narrative

Additional narrative: philips has investigated this complaint.According to the information collected, during a diagnostic procedure, the l-arm cover detached after a collision with the operation light.The cover was retained by the safety chain and the procedure was completed as planned.A philips service engineer inspected the system onsite and identified that the cover could not be reseated due to a crack.The engineer replaced and installed the l-arm cover and returned the system to use in good working order.Corrected data: codes were updated as per the investigation outcome.

• Brand Name: AZURION
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 4-6; best 5684 PC; NL 5684 PC
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 4-6; best 5684 PC; NL 5684 PC
• Manufacturer Contact: dusty leppert ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 14235378
• MDR Text Key: 290274601
• Report Number: 3003768277-2022-00183
• 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,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: 04/28/2022
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/04/2021
• 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