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 08/18/2022

Event Type  malfunction  

Event Description

It has been reported to philips that during a planned treatment, the l-arm rotation cover was hit by the lead shield and detached.It was not retained by the safety chain and brushed the patient as it fell.The cover was moved out of the way and the case was continued.No harm has been reported to philips.Philips has started an investigation of this complaint.

Manufacturer Narrative

Philips has investigated this complaint.During the investigation philips has confirmed that the l-arm cover did not retain as the clip for the chain was bent open.The philips engineer replaced and reinstalled the l-arm cover.The system was returned to use in good working order.Philips has completed a good faith effort to collect patient information.However, the customer has not provided the requested information.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 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: 15425837
• MDR Text Key: 300257693
• Report Number: 3003768277-2022-00425
• Device Sequence Number: 1
• Product Code: OWB
• UDI-Device Identifier: 00884838085268
• UDI-Public: 00884838085268
• Combination Product (y/n): N
• Reporter Country Code: US
• 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

• Date FDA Received: 09/15/2022
• 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: 08/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2020
• 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
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 61 KG