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

Model Number AZURION 7 M12

Device Problem Mechanical Jam (2983)

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

Event Date 01/28/2023

Event Type  malfunction  

Event Description

It has been reported to philips that the system was down due to geometry errors.No harm has been reported to philips.Philips has started an investigation of this complaint.

Manufacturer Narrative

Philips has investigated this complaint.A philips field service engineer (fse) visited the site and confirmed that the system was down due to geometry errors.Review of the system log file showed failing power on self-test (post) error which is related to table longitudinal movement.As a part of repair activity, the fse replaced the node interface unit and calibrated the table longitudinal position.After replacement and calibration, the system was returned to use in good working order.The codes were updated based on the investigation outcome.The 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: dusty leppert ; boschdijk 525; postbus 90050; eindhoven 5600 -PB ; NL 5600 PB
• MDR Report Key: 16384579
• MDR Text Key: 309645586
• Report Number: 3003768277-2023-00871
• Device Sequence Number: 1
• Product Code: OWB
• UDI-Device Identifier: 00884838085251
• UDI-Public: 00884838085251
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K163715
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/28/2023
• Initial Date FDA Received: 02/16/2023
• Supplement Dates Manufacturer Received: 12/25/2023
• Supplement Dates FDA Received: 12/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/17/2020
• 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