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 09/15/2014

Event Type  malfunction  

Manufacturer Narrative

Correction, original report should read: product code: oxo.Common device name: image-intensified fluoroscopic x-ray system, mobile.

Event Description

A site representative, radiographic technologist (rt), reported an o-arm 1000 imaging system dose report, taken in a spine procedure the previous day, was lower than expected.No further details of the procedure were provided.There was no impact on patient outcome.

Manufacturer Narrative

Patient information was unavailable from the site, neurocoordinator declined to provide demographics.Rma issued.Replacement control board shipped to site 09/18/2014; suspect device returned to manufacturer 10/02/2014.Rma issued.Replacement pleora shipped to site 09/18/2014; suspect device returned to manufacturer 10/02/2014.Software investigation found that the reported event was related to a software issue.This issue was documented in a medtronic navigation software anomaly tracking database.09/24/2014 a medtronic representative performed an imaging system check-out and reported replacing the control board and pleora; system functioned normally.

Manufacturer Narrative

The control board and pleora box components of the imaging system were returned to the manufacturer for analysis.Both components ran without issue on a test system.The components were found to be fully functional with no problem found.

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. (LITTLETON); 300 foster street; littleton MA 01460 9710
• Manufacturer Contact: amos jarrette ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902082
• MDR Report Key: 4174404
• MDR Text Key: 16212086
• Report Number: 1723170-2014-01086
• 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,Company Representative,company represent
• Reporter Occupation: Radiologic Technologist
• Type of Report: Initial,Followup,Followup
• Report Date: 10/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2014
• 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: 10/02/2014
• Is the Reporter a Health Professional?: Yes
• 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