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 10/11/2021

Event Type  malfunction  

Event Description

It has been reported to philips that during a planned procedure, the z-rotation motion stopped.A loud noise was heard and the z-rotation motor assembly and z-rotation cover got detached from the l-arm.The motor assembly was retained by a cable (d-type connector) and the z-rotation cover by its retaining safety chain.No harm or damage to property has been reported to philips.Philips has started an investigation for this complaint.

Manufacturer Narrative

Philips investigated the reported event.According to the information collected, the system was in clinical use, however the procedure (non-emergency treatment) had been concluded when the issue occurred.There was no impact to the patient/user.Philips investigated the reported issue and confirmed that the motor assembly was retained by a cable (d-type connector) and the z-rotation cover by its retaining safety chain.However, the z-rotation motor assembly and z-rotation cover got detached from the l-arm.An initial analysis of the z-rotation motor assembly was performed, and it was found to be caused due to the gearbox mounting/output flange separating (coming loose) from the gearbox housing/assembly, resulting in a loss of position fixation of the z-rotation motor assembly.The z-rotation assembly was replaced, and the system was returned in good working order.

• 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: 12681409
• MDR Text Key: 277905344
• Report Number: 3003768277-2021-10190
• Device Sequence Number: 1
• Product Code: OWB
• UDI-Device Identifier: 00884838085268
• UDI-Public: 00884838085268
• Combination Product (y/n): N
• Reporter Country Code: GR
• PMA/PMN Number: K181830
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,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

• Date FDA Received: 10/22/2021
• 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: 10/11/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/09/2018
• 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