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

Catalog Number BI70002000

Device Problems Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Display or Visual Feedback Problem (1184)

Patient Problem No Patient Involvement (2645)

Event Date 02/16/2018

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.Device manufacturing date is unavailable.A medtronic representative went to site to test the equipment.Representative was unable to replicate the reported issue after the system was rebooted.A system checkout was performed and the hardware, software, and instruments passed the system checkout.The system was found to be fully functional.No parts were replaced.No parts have been received by the manufacturer for evaluation.

Event Description

A medtronic representative reported that while outside of procedure, when turning on the mobile view station (mvs) without the image acquisition system (ias) plugged in, the viewing station booted to a blue screen.Rebooting the system did not resolve the issue as the system booted to blue screen again.Rebooting it the third time resolved the issue and the viewing station booted fully.During troubleshooting, representative reported that after initial review of logs, there were issues with database not initialized or could not create bi database.There was no patient present at the time of the issue.

Manufacturer Narrative

Additional information: manufacture date provided in appropriate field.Additional information: udi has been updated to proper value.

Manufacturer Narrative

A software analysis was initiated.However, the software evaluation found that a probable cause was unable to be determined.

• 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: heather davis ; navigation customer quality; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902515
• MDR Report Key: 7329079
• MDR Text Key: 102078219
• Report Number: 1723170-2018-01090
• Device Sequence Number: 1
• Product Code: OWB
• 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: 06/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Radiologic Technologist
• Device Catalogue Number: BI70002000
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2018
• 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