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

Catalog Number BI70002000-G30

Device Problems Device Inoperable (1663); Calibration Problem (2890); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 10/31/2017

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.A medtronic representative inspected the imaging system onsite and confirmed it would not calibrate motion.The representative reported that upon boot up the system requested to hold the 'm' button to calibrate motion, but it would not calibrate and stopped the gantry moving in the 'y' direction.Upon trouble shooting, the gantry could move as normal in any direction with the pendant, but after removing the x-stage bellows cover and invalidating home, calibration was still unsuccessful.The positioner controller was replaced (firmware updated) and the issue was resolved.A full imaging system check-out was completed following part replacement and all tests passed.Full system functionality was confirmed and the system was returned to service.The suspect part has been returned to the manufacturer for evaluation, however results are not available at this time.

Event Description

A site representative reported that outside of a procedure, the imaging system took a long time to calibrate motion.The site reported that the motion was difficult to calibrate and took 10 minutes for the procedure to finalize.Four attempts were made to calibrate motion.The longest the m button was held was 53 minutes.The system was going up and down, but it was not possible to get side to side motion calibration.There was no patient present when this issue was observed.The cases at the site will continue as scheduled with a c-arm system.

Manufacturer Narrative

The position motion controller was returned to the manufacturer for analysis.The controller was found to be fully functional with no problem found.The reported event could not be duplicated by medtronic personnel.

• 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: 7064630
• MDR Text Key: 93596837
• Report Number: 1723170-2017-04839
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Radiologic Technologist
• Device Catalogue Number: BI70002000-G30
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/07/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1