MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STRE SIEMENS ORBIC C-ARM IMAGING SYSTEM; IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE

Device Problem Poor Quality Image (1408)

Patient Problem Insufficient Information (4580)

Event Date 06/02/2016

Event Type  malfunction  

Event Description

A medtronic representative reported that navigation was discontinued during a spinal fusion case due to image quality with a siemens orbic c-arm.She reported that the site had new users running the c-arm and it took them 10 minutes to acquire a scan, once the scan was acquired the image quality was poor and the surgeon decided to discontinue navigation.There was no reported impact to the outcome of the patient.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: SIEMENS ORBIC C-ARM IMAGING SYSTEM
• Type of Device: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE
• Manufacturer (Section D): SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STRE
• MDR Report Key: 17527707
• MDR Text Key: 321416858
• Report Number: MW5134639
• Device Sequence Number: 1
• Product Code: OXO
• 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: 06/08/2016

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?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1
• Patient Age: 69 YR