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

Model Number AZURION 7 M20

Device Problems Operating System Becomes Nonfunctional (2996); Activation Failure (3270)

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

Event Date 11/18/2022

Event Type  malfunction  

Event Description

It has been reported to philips that the system went into reboot sequence immediately.No harm has been reported to philips.To date, no further information was received.We are conservatively reporting this event as the investigation is ongoing.A follow up report will be submitted when further information is received.

Manufacturer Narrative

Philips has investigated this complaint.According to the additional information collected, the system was in clinical use when the issue occurred.The philips field service engineer (fse) inspected the system onsite and confirmed that the system went into reboot sequence immediately.Upon further inspection fse found issues with the cat5 cable from ups to m cabinet faulty.The fse replaced the cat5 cable from ups to m cabinet.After replacement of the cable, the system was returned to use in good working order.The codes were updated based on the investigation outcome.The device problem code was corrected.

• 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: 15872786
• MDR Text Key: 304514986
• Report Number: 3003768277-2022-01227
• Device Sequence Number: 1
• Product Code: OWB
• UDI-Device Identifier: 00884838099258
• UDI-Public: 00884838099258
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200917
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 722224
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/18/2022
• Initial Date FDA Received: 11/28/2022
• Supplement Dates Manufacturer Received: 11/09/2023
• Supplement Dates FDA Received: 11/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/14/2021
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1