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)

Patient Problem No Patient Involvement (2645)

Event Date 07/20/2017

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.On (b)(6) 2017 a medtronic representative went to the site to test the equipment.Representative reported upon reboot the system displayed hold m button to calibrate motion but when the button is pressed the system would not calibrate and stopped the gantry moving in the y-direction.Testing revealed that the gantry stooped about a foot off the ground and the process of motion calibration was stopped.Gantry could be moved in any direction using pendant.Removing the x-stage, bellow covers, invalidating home and rebooting the system did not resolved the issue.Dmc smart terminal and remote desktop had the positioner/gantry at verified and run level 6.At this point representative moved the gantry downward about an inch off the ground and set run level 8 for the positioner and pressed m.The representative was now able to move past motion calibration.Rebooted the imaging system and the system booted up normally.Invalidating home again to verify calibration and the system passed as normal.Rebooted the system several times and system booted up normally.System is functioning normally.No parts were replaced.No parts have been received by manufacturer for evaluation.

Event Description

A medtronic representative reported that while outside of a procedure the imaging system would not allow the representative to calibrate motion.This was discovered during a planned maintenance (pm).There was no patient present at the time of the issue.

Manufacturer Narrative

Correction: unique device identification (udi) updated to proper value.The logs for the imaging system were reviewed by medtronic personnel.However, the logs provided no additional insight into the probable cause of the anomaly.The software investigation found that a probable cause was unable to be determined without further information since the on-going investigation proved to be inconclusive based on the information provided.

• 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 ; attn:product quality experienc; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902515
• MDR Report Key: 6793651
• MDR Text Key: 82664579
• Report Number: 1723170-2017-03309
• 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: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 12/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2017
• 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?: No
• Date Manufacturer Received: 11/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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