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

Model Number AZURION 7 M20

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 04/27/2022

Event Type  malfunction  

Event Description

It has been reported to philips that the horizontal beam disc (cover) of the flexarm became detached.The cover was retained by its safety chain.No harm has been reported to philips.Philips has started an investigation of this complaint.

Manufacturer Narrative

Add mfr narr: philips has investigated the reported problem.The flexarm horizontal beam disc became detached during a vascular procedure.It was initially reported that the cover was retained by its safety chain, however the flexarm horizontal beam disc is not fitted with a safety chain, but instead has a locking clip and cord attached for serviceability purpose.The flexarm horizontal beam disc is mounted with a rotation based locking mechanism, supported by 5 support points.A philips service engineer inspected the system on site.The cause of the flexarm horizontal beam disc detaching could not be determined.The engineer reinstalled the flexarm horizontal beam disc, after which the system was returned to use in good working order.Corrected data: coding updated based on investigation.

• 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: 14488229
• MDR Text Key: 292502893
• Report Number: 3003768277-2022-00244
• Device Sequence Number: 1
• Product Code: OWB
• UDI-Device Identifier: 00884838085268
• UDI-Public: 00884838085268
• Combination Product (y/n): N
• PMA/PMN Number: K181830
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AZURION 7 M20
• Device Catalogue Number: 722079
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/27/2022
• Initial Date FDA Received: 05/24/2022
• Supplement Dates Manufacturer Received: 04/27/2022
• Supplement Dates FDA Received: 11/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/18/2019
• 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