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

Model Number AZURION 7 B20

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 11/20/2023

Event Type  malfunction  

Event Description

It has been reported to philips that the c-arm cover fell off.The issue was found during clinical use.No harm has been reported to philips.Philips has started an investigation of this complaint.

Manufacturer Narrative

Philips has investigated this complaint.The philips field service engineer (fse) inspected the system onsite and confirmed that the c-arm cover had fallen off.During troubleshooting, the fse attempted to re-attach the cover but found that it couldn't be reattached.The fse handed over the system to customer with limitations.The fse fitted a new cover for the lateral tube in the follow up work order.After replacing the cover, the system was returned to use in good working order.The codes were updated based on the investigation outcome.

• 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: 18226377
• MDR Text Key: 329215217
• Report Number: 3003768277-2023-06591
• Device Sequence Number: 1
• Product Code: OWB
• UDI-Device Identifier: 00884838085367
• UDI-Public: 00884838085367
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AZURION 7 B20
• Device Catalogue Number: 722068
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/20/2023
• Date Device Manufactured: 12/20/2017
• 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