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

Model Number AZURION 7 M20

Device Problem Break (1069)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/30/2023

Event Type  malfunction  

Event Description

It has been reported to philips that the c-arm broke resulting in yanking a patient's shoulder.Also the arm support board was broken.The patient outcome is unknown and it is unknown if there was actual harm to the patient.Philips is collecting additional information.We are conservatively reporting this event as an injury while the investigation is ongoing.

Manufacturer Narrative

Philips has investigated this complaint.According to the additional information collected, the system was in clinical use for treatment when the issue occurred and the patient's shoulder was pulled back but the patient was unharmed, and no injury occurred to the patient and the procedure was completed as planned.The customer reported that the c-arm cable caught the arm board on rotation and broke the arm board.The customer ordered and replaced the arm support board.After replacement of the arm support board, 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: dusty leppert ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 17096643
• MDR Text Key: 316848805
• Report Number: 3003768277-2023-03493
• Device Sequence Number: 1
• Product Code: OWB
• UDI-Device Identifier: 00884838085268
• UDI-Public: 00884838085268
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K163715
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2023
• 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
• Date Manufacturer Received: 09/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/22/2019
• 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