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); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 12/06/2017

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.The issue was resolved through trouble shooting the imaging system.The system was initialized and the motion control board was started up with no issues.It was possible to calibrate the system movements and the system as able to function properly.No parts were replaced or returned to the manufacturer for evaluation.Resolution confirmed on call.

Event Description

A medtronic representative reported that while setting up for a case, the imaging system would not process past 'system initializing please wait'.The batteries were fully charged and the system was used 7 days prior.Several attempted reboots were made, with no change in status.The system pendant is showing ready on motion, ready on radiation, the mobile view station (mvs) shows ready, however the system remains initializing.There was no patient present when this issue was identified.The site will proceed with a c-arm.

Manufacturer Narrative

A medtronic representative went to the site to test the equipment.Testing revealed that the imaging system passed functional testing.The imaging system then passed the system checkout and was found to be fully functional.A software analysis was initiated to determine the probable cause of the issue through log analysis.Analysis found that the reported event was related to a software issue.This issue was documented in a medtronic navigation software anomaly tracking database.

• 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 ; 7635267745
• MDR Report Key: 7157685
• MDR Text Key: 96224177
• Report Number: 1723170-2018-00017
• 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,health
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 04/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2018
• 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: 04/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2016
• 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