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

Catalog Number BI70002000-G30

Device Problems Electrical /Electronic Property Problem (1198); Device Emits Odor (1425)

Patient Problem No Patient Involvement (2645)

Event Date 06/27/2017

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.On (b)(6) 201 a power conversion was shipped to site.On (b)(6) 2017 a medtronic representative went to the site to check the system.Representative reported that all motors lost power and was stuck in docking position.The power conversion was replaced and a system checkout was performed.The hardware, software, and instruments passed the system checkout.The system was found to be fully functional.The suspect power conversion was received by manufacturer and is being evaluated.

Event Description

A site representative reported that the image acquisition system (ias) of the imaging system had a burning odor and was unable to drive.Representative also mentioned that the batteries died and the drive is was not working.There was no patient present at the time of the issue.

Manufacturer Narrative

Correction: mfg date updated.

Manufacturer Narrative

The power enclosure for the imaging system was returned to the manufacturer for evaluation.Testing found that the board had two resistors that were open.

• 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 ; 7208902515
• MDR Report Key: 6725594
• MDR Text Key: 80457925
• Report Number: 1723170-2017-03002
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Radiologic Technologist
• Device Catalogue Number: BI70002000-G30
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/08/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1