MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LITTLETON) O-ARM 1000 IMAGING SYSTEM; IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE

Model Number BI-700-00027-120

Device Problems Mechanical Problem (1384); Calibration Problem (2890)

Patient Problem No Patient Involvement (2645)

Event Date 11/29/2017

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.A medtronic representative reported that the x-stage cover was removed, re-homing was performed and straightened the x-stage cover which resolved the issue.A system checkout was performed and the hardware, software, and instruments passed the system checkout.The system was found to be fully functional.No parts were replaced.No parts have been received by the manufacturer for evaluation.

Event Description

A medtronic representative reported that during planned maintenance (pm),when the imaging system was powered on, the first bar on the pendant displayed"to calibrate motion hold m button".Representative confirmed with site that the system was not docking with the docking button on pendant and the site was using xyz button to dock the system.There was no patient present at the time of the issue.

Manufacturer Narrative

Review of this event and/or additional information received shows that there is no evidence to reasonably suggest that the device in this report or a similar device would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.Therefore, this event did not and does not meet the reporting requirements stipulated in 21 cfr 803.

• Brand Name: O-ARM 1000 IMAGING SYSTEM
• Type of Device: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE
• 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: stephanie riley ; navigation customer quality; 826 coal creek circle; louisville, CO 80027-9710 ; 7635267745
• MDR Report Key: 7143828
• MDR Text Key: 95793120
• Report Number: 1723170-2017-05265
• Device Sequence Number: 1
• Product Code: OXO
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K050996
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 06/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Radiologic Technologist
• Device Model Number: BI-700-00027-120
• Device Catalogue Number: 9732719
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/29/2017
• Initial Date FDA Received: 12/22/2017
• Supplement Dates Manufacturer Received: 06/14/2018
• Supplement Dates FDA Received: 06/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2010
• 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