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

Catalog Number BI70002000

Device Problems Device Inoperable (1663); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 05/22/2018

Event Type  malfunction  

Manufacturer Narrative

A medtronic representative went to the site to test the equipment.Testing revealed that the mvs computer was taking an inordinate amount of time to boot into the application.The computer would remain in the post screen for approximately 20 minutes before it would eventually proceed.During troubleshooting, representative discovered that the power connection for the external dvd rom drive had become partially disconnected.After re-seating the power connection for the external drive, and the subsequent boot attempts of the mvs computer produced expected results.The imaging system then passed the system checkout and was found to be fully functional.The suspected computer was returned as unused.

Event Description

Medtronic received information regarding an imaging device being used outside of a procedure.It was reported that the mobile view station (mvs) computer would not boot into the os.This was discovered during a planned maintenance (pm).No patient was present.

• 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: koko tyler ; navigation customer quality; 826 coal creek circle; louisville, CO 80027 ; 7208903200
• MDR Report Key: 7611876
• MDR Text Key: 111434412
• Report Number: 1723170-2018-02843
• 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
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 06/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Radiologic Technologist
• Device Catalogue Number: BI70002000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2017
• 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