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 Application Program Problem: Dose Calculation Error (1189); Device Issue (2379); Improper Device Output (2953)

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

Event Date 08/18/2014

Event Type  malfunction  

Manufacturer Narrative

The root cause of the reported issue was a software anomaly.The mobile viewing station computer was replaced on the system as well.It was determined that the computer had a corrupt operating system as well.After computer replacement the system has been functioning properly.Mobile viewing station computer evaluation results are as follows: the reported problem was due to software anomaly.Mvs computer was found to have an intermittent problem with the harddrive; initially c and d drives were shown as c, d, e, f instead of c1, c2, d1, d2.Once installed in the mvs station, it received boot up config error at power up on the mvs screen.Corrupted operating system.

Event Description

A medtronic representative reported an o-arm 1000 imaging system dose report containing lower values than expected from a prior spine procedure on (b)(6) 2014.No further details regarding the previous procedure were provided.There was no impact on patient outcome reported.

Manufacturer Narrative

(b)(6).Rma issued.Replacement mvs computer shipped to site 08/26/2014.Medtronic investigation of returned suspect mvs computer not completed.(b)(6) 2014 a medtronic representative performed an imaging system check-out, changed mvc computer and all areas passed.System performed as intended.

Manufacturer Narrative

A capa was created to address the reported incident.Based on the capa investigation, the identified root cause for this event was that the operator changes the gui parameters between the end of scan and when dose report commanded.This is an unanticipated sequence of user action outside of the typical post-operative workflow when the dose report is uploaded for possible accumulation into the patients' lifetime dose records.

• 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.; 826 coal creek circle; louisville CO 80027 9710
• Manufacturer Contact: amos jarrette ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902082
• MDR Report Key: 4115941
• MDR Text Key: 12616458
• Report Number: 1723170-2014-01022
• 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: Company Representative,company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 10/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2014
• 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: 09/09/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/26/2009
• 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