MAUDE Adverse Event Report: SIEMENS INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Device Problems Misconnection (1399); Defective Component (2292)

Patient Problem Insufficient Information (4580)

Event Date 12/16/2014

Event Type  malfunction  

Event Description

"during a posterior spinal fusion case, 3d spin with siemens c-arm would not begin.Error popped up on the c-arm console stating no connectivity to navigation system.After a 30 minute delay in procedure to troubleshoot all navigation connections, it was determined the port was defective on siemens c-arm.This case was completed successfully with navigation once the port was determined to be the problem.Additional anesthesia was not needed to her knowledge.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS
• MDR Report Key: 17529750
• MDR Text Key: 321384965
• Report Number: MW5136674
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1