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 Device Emits Odor (1425); Device Issue (2379)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/27/2015

Event Type  malfunction  

Event Description

A site biomed representative reported that, during a spine procedure, their imaging system had a burning smell while it was turned off and charging.The site proceeded to use the imaging system for one spin, however, the smell remained.There was no delay to the procedure.The imaging system was removed from the operating room (or) after the spin was taken.The surgeon completed the procedure with the use of the navigation system.There was no impact on patient outcome.

Manufacturer Narrative

(b)(4).Return requested.Replacement battery charger 2 shipped to site 01/28/2015.Suspect battery charger 2 not expected to be returned to manufacturer for analysis.Return requested.Replacement motor battery charger shipped to site 01/28/2015.Suspect motor battery charger returned to manufacturer on 02/14/2015 and is under analysis.Return requested.Replacement battery charger 1 shipped to site 01/28/2015.Suspect battery charger 1 returned to manufacturer on 02/14/2015 and is under analysis.Return requested.Replacement battery charger 2 shipped to site 01/28/2015.Suspect battery charger 2 returned to manufacturer on 02/14/2015 and is under analysis.At 01/29/2015 replaced 8 pack battery kit.Suspect device not returned to manufacturer for analysis.At 01/29/2015 return requested.Replaced 6 pack battery kit.Suspect 6 pack battery kit not returned to manufacturer for analysis.Medtronic representative replaced motors chargers board, inverter charger 1, and inverter charger 2.Replaced all x-ray and motion batteries.At 01/29/2015 a medtronic representative performed an imaging system check-out, all areas passed.System performed as intended.No further issues have been reported.

Manufacturer Narrative

Patient id, weight and age provided.Patient sex was unavailable.Battery charger board 1 returned and evaluated: battery charger 1 failed bench level test.Channel a output voltage was at 0v, sense voltage was also at 0v.Channel c output no load output voltage was measured as 36.82v [expected was 27.5+-1.5]; channel d output no load output voltage was measured as 32.02v [expected was 27.5+-1.5]; charger board was found to have an electrical malfunction.Battery charger board 2 was returned and found to be fully functional.A second battery charger board 2 and motor battery charger board were returned unused.Batteries were not returned.Issue resolved after part replacements reported on initial 3500a.System is fully functional.

• 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 971
• Manufacturer Contact: catherine eaton ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902092
• MDR Report Key: 4547411
• MDR Text Key: 5520471
• Report Number: 1723170-2015-00236
• Device Sequence Number: 1
• Product Code: OXO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050996
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 01/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2015
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/11/2009
• 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
• Patient Age: 68 YR
• Patient Weight: 113