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

Model Number AZURION 7 M20

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 12/06/2023

Event Type  malfunction  

Event Description

It has been reported to philips that the z-rotation cover has a possibility to fall off.No harm has been reported to philips.Philips has started an investigation of this complaint.

Manufacturer Narrative

Philips has performed a review of this event.The reported event is regarding a customer inquiry about the field safety corrective action (fsca) 2022-igt-bst-002.Customer has two devices affected by fsca 2022-igt-bst-002.After receiving the field safety notice associated to this fsca, customer contacted philips to request implementation of the correction in a third device.Philips informed the customer that this third device for which they requested implementation of the correction is not affected by fsca 2022-igt-bst-002.There was no allegation of a product malfunction and there was no actual event.Based on this information, philips concludes that this event is not reportable.H3 other text : manufacturer evaluation cancelled; no further investigation required.

• 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: 19011104
• MDR Text Key: 339001767
• Report Number: 3003768277-2024-01992
• Device Sequence Number: 1
• Product Code: OWB
• UDI-Device Identifier: 00884838085268
• UDI-Public: 00884838085268
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 04/01/2024
• 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
• Date Manufacturer Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/03/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1