MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LITTLETON) O-ARM 1000 IMAGING SYSTEM; IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE

Model Number BI-700-00027-120

Device Problem Failure to Fire (2610)

Patient Problem No Patient Involvement (2645)

Event Date 04/26/2016

Event Type  malfunction  

Manufacturer Narrative

There was no patient involved with this concern.A medtronic representative went to the site to test the equipment.The image acquisition system (ias) had lost its config file.The rep restored it from an earlier back-up.The rep replaced the ias computer as a proactive measure.The imaging system then passed the system checkout and was found to be fully functional.The power board was returned unused.The ias computer was returned and is currently under analysis.The software investigation found that the reported event was related to a software issue.This issue was documented in a medtronic navigation software anomaly tracking database.

Event Description

A medtronic representative reported that the imaging system was stuck in system booting please wait.The system was rebooted multiple times with no change.There was no patient involved with this concern.

Manufacturer Narrative

The suspect ias computer was returned to the manufacturer for analysis.The device was found to be fully functional with no problem found.Virus scan was successfully performed.Time/date check (cmos check) was good.The computer was installed on the test image system.The system readied as expected at each power cycle and both 2d and 3d imaging were successful.No problem found.The reported event could not be duplicated by medtronic personnel.

• Brand Name: O-ARM 1000 IMAGING SYSTEM
• Type of Device: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE
• 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: kristianna bilan ; 826 coal creek circle; louisville, CO 80027 ; 7208902338
• MDR Report Key: 5674794
• MDR Text Key: 45749570
• Report Number: 1723170-2016-00921
• Device Sequence Number: 1
• Product Code: OXO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050996
• 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
• Report Date: 07/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Medical Equipment Company Technician/Representative
• Device Model Number: BI-700-00027-120
• Device Catalogue Number: 9732719
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/10/2008
• 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