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 rep found that no rad/fluoro calibration had been performed in 130 days and the config.Xml file was corrupted causing the imaging system application not to load properly due to the correct config file being unavailable.The rep restored the config file and the system booted up correctly.The imaging system was then found to be fully functional.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 did not boot up.There was no patient involved with this concern.

• 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: amos jarrette ; 826 coal creek circle; louisville, CO 80027 ; 7208902082
• MDR Report Key: 5673698
• MDR Text Key: 45717373
• Report Number: 1723170-2016-00922
• Device Sequence Number: 1
• Product Code: OXO
• Combination Product (y/n): N
• PMA/PMN Number: K050996
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 05/23/2016

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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2013
• 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