MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LITTLETON) O-ARM 1000 IMAGING SYSTEM 3RD EDITION; IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE

Model Number BI-700-00028-120

Device Problem Failure to Fire (2610)

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

Event Date 04/21/2016

Event Type  malfunction  

Manufacturer Narrative

A medtronic representative went to the site to test the equipment.The following is a summary of the testing and findings: on 4/21 - the generator is not booting and giving an error 11.K5 & k6 are not engaging.Standalone board has proper input but is only putting out ~60vac.Standalone and atp boards ordered.On 4/22 - parts were not delivered.On 4/25 - parts did not fix problem.Found f6 fuse holder had damage at the connector for the wire.Repaired and now k5 engages but generator is still giving an error 11.The charge/discharge monitor board is faulty.Ordering a large amount of parts to cover any other issues that i might not be able to currently see.On 4/27 - replaced charge/discharge board.System booted and seemed fully functional.Performed max output calibration required due to atp swap.I then did additional exposures to test functionality when the generator started to give an error 25 (battery issue).Again, i verified the batteries were good.After a couple more exposures there was a loud pop from the generator and the system turned itself off.After a couple checks i tried to turn the system back on and the in-rush resistor blew.Damage cannot be repaired in the field.On 5/2 - this system was swapped out with loaner unit and shipped back to manufacturer for repair.Several components have been returned and are currently under analysis.

Event Description

A medtronic representative reported that during a spine surgery the site told him after their last spin they heard a popping noise and the system shut off.They turned the system back on and drove it out of the room, now it is showing a generator error.Navigation was used to complete the surgery with no impact to the outcome of the patient.

Manufacturer Narrative

Medtronic investigation of returned suspect standalone board finds that the board is fully functional.The returned board passed bench testing.As previously reported, the field service engineer replaced the board during troubleshooting however the standalone board did not resolve the issue.Medtronic investigation of returned suspect charge/discharge (inverter) board finds that the reported issue was confirmed.Bench testing confirmed charge/discharge board bad due to a q1 short.The failure of the charge/discharge (inverter) board was confirmed to be due to an electrical failure.

Manufacturer Narrative

The atp console board was tested and found to be fully functional.Installed atp console in the imaging test system and the system readied and functioned as expected.2d and 3d imaging were successful.No problem found.Pcb controller was tested and found fully functional.The controller was installed in the imaging test system and it functioned as expected.System ready and both 2d and 3d imaging were successful.No fault found with board.Interface control board confirmed the "error 11." installed in system in conjunction with associated ht controller board.Visual inspection did not note damage to board before installation.At installation of the interface control board into the imaging test system, the system began beeping and generator error 11 was noted.Ds1 was off on the charge/discharge board.Input transformer fuse j6 opened.Removed ht controller board and interface control board.At this time, the k8 solder runs for p5 pins 12 and 14 were blown on interface control board.The failure of the interface control board was confirmed to be due to an electrical failure.

• Brand Name: O-ARM 1000 IMAGING SYSTEM 3RD EDITION
• 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: kristianna bilan ; 826 coal creek circle; louisville, CO 80027 ; 7208902338
• MDR Report Key: 5664726
• MDR Text Key: 45478354
• Report Number: 1723170-2016-00872
• Device Sequence Number: 1
• Product Code: OXO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092564
• 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,Followup
• Report Date: 07/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Radiologic Technologist
• Device Model Number: BI-700-00028-120
• Device Catalogue Number: BI70000028120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/21/2014
• 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