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 Failure to Fire (2610); Application Program Problem (2880)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/23/2018

Event Type  malfunction  

Manufacturer Narrative

Patient information was unavailable from the site.A medtronic representative went to the site to test the equipment.Testing revealed that the system needed motion calibration to fix abrupt movement, the frontal cover was broken, their was noise inside the gantry when the tube was moving, their was intermittent disconnection of the x-ray system, then pendant was opaque due to the cleaner used, the power cable was damaged, and the hand switch's plastic cover was broken.Quotes to replace the damaged parts were generated for the site.

Event Description

Medtronic received information regarding a navigation device being used for a procedure.The issue occurred intraoperatively and caused no delay to the surgery.It was reported that the communication between the image acquisition system (ias) and the mobile view station (mvs) was lost during the procedure.The pendant screen showed the ¿three status bars¿ display with he x-ray going up, but not finishing.The system was rebooted 2 or 3 times, the equipment worked, and the procedure was completed.There was no impact on patient outcome.At the end of the procedure, the customer tried to check exposure, but the pendant showed the three status bars again and it was necessary to reboot the system again to open the door.

Manufacturer Narrative

A software analysis was initiated.However, the software evaluation found that a probable cause was unable to be determined.

Manufacturer Narrative

A medtronic representative went to the site to test the equipment.Testing revealed that communication between ias and mvs was lost during procedure." o-arm application 3.1.6 started successfully.Time/date check (cmos check) and virus scan were successful." installed ias computer in system 267.Motion, x-ray and communication readied.Invalidate home was successful.Fluoro and rad gain calibration passed.3d and 2d images were acquired successfully as well as image retrieval.No functional problem found.The imaging system then passed the system checkout and was found to be fully functional.A medtronic representative went to the site to test the equipment.Testing revealed that unable to confirm reported complaint,"communication between ias and mvs was lost during procedure." "power switching board was installed in o-arm test system 267.The system booted and readied as expected multiple times.2d imaging, 3d imaging, and all motion and logic were successful.No fault found.The imaging system then passed the system checkout and was found to be fully functional.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: a medtronic representative went to the site to test the equipment.Testing revealed that replacing the power switching board and actualization of software resolved the issue.The system then passed the system checkout and was found to be fully functional.No parts have been received by the manufacturer for evaluation.If information is provided in the future, a supplemental report will be issued.

• 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: peter verhey ; navigation customer quality; 826 coal creek circle; louisville, CO 80027-9710
• MDR Report Key: 7786199
• MDR Text Key: 117264833
• Report Number: 1723170-2018-04079
• Device Sequence Number: 1
• Product Code: OXO
• Combination Product (y/n): N
• PMA/PMN Number: K050996
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BI-700-00027-120
• Device Catalogue Number: 9732719
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/06/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/22/2013
• 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