MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LITTLETON) O-ARM O2 IMAGING SYSTEM; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Catalog Number BI70002000-G27

Device Problem Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/26/2018

Event Type  malfunction  

Manufacturer Narrative

A medtronic representative went to the site to test the equipment.While testing, the ground prong of the power cord was loose.While testing, it was also noted that the computer of the hard drive had a raid volume of 0 and that the physical device had an error at startup.Following installation of a new computer and power cord, functionality was restored to the imaging system.It was reported that the software of the imaging system was updated as well.The imaging system then passed the system checkout and was found to be fully functional.The software investigation found that the reported event was unrelated to a software issue.The software functioned as designed.No parts have been received by the manufacturer for evaluation.

Event Description

A manufacturer representative reported that, while in a spinal fusion, the viewing station of the imaging system became unresponsive following an image acquisition.It was reported that reseating the interface (umbilical) cable did not restore functionality.Once restarted, the system functioned as designed.It was noted that the original image acquisition was on the imaging system and the site was able to continue with the procedure.There was a reported delay to the procedure of less than 1 hour due to this issue.There was no reported impact on patient outcome.No additional information was provided.

Manufacturer Narrative

The power cord for the viewing station was returned to the manufacturer for analysis.Analysis found that the cable failed continuity testing as a ground wire was open.Analysis found that the reported event was related to a electrical issue.

Manufacturer Narrative

The computer for the viewing station of the imaging system was returned to the manufacturer for evaluation.Testing found that the hard drives on the unit were misaligned.Once aligned, the unit functioned as designed.

• Brand Name: O-ARM O2 IMAGING SYSTEM
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LITTLETON); 300 foster street; littleton MA 01460
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC. (LITTLETON); 300 foster street; littleton MA 01460
• Manufacturer Contact: peter verhey ; navigation customer quality; 826 coal creek circle; louisville, CO 80027-9710
• MDR Report Key: 7362279
• MDR Text Key: 103270035
• Report Number: 1723170-2018-01231
• Device Sequence Number: 1
• Product Code: OWB
• UDI-Device Identifier: 00643169639683
• UDI-Public: 00643169639683
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151000
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup
• Report Date: 06/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Radiologic Technologist
• Device Catalogue Number: BI70002000-G27
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2016
• 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: 67 YR
• Patient Weight: 77