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 Break (1069); Calibration Problem (2890); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 08/26/2015

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.Field system engineer was informed by the site about a green splash screen on the mvs with an error message "could not load config file to ias" and the system wouldn't fully boot.Upon further onsite investigation, the engineer discovered that the mobile view station's configuration files were corrupted, the engineer also discovered that the ethernet port kit along with the ethernet cable were damaged.Field system engineer was able to resolve the issue by re-loading the configuration files and replacing the ethernet port kit.No further issues were reported.There was no patient present when this issue was identified.System passed all tests during system checkout and no further action is required at this time.This event was identified during a retrospective review as discussed with the (b)(6) district office on (b)(6) 2016 via medtronic navigation, inc.Response to (b)(6) 2016 (b)(4).This review was performed as a result of recent changes/improvements to the medtronic navigation, inc.Medical device report (mdr) review process and is for non-adverse event reportable malfunctions within the last two years where the reported malfunction was not previously associated with serious injuries.Similar malfunctions that had resulted in significant delays of surgery or required additional intervention had been reported as mdr serious injuries.Based on this 483 observation, the reporting determination has been revised to consider these malfunction events reportable.This process change resulted in an overall increase in the number of mdrs filed by medtronic navigation, inc., since april 2016.It should be noted that this increase is not the result of the discovery of new product problems, but rather the result of a broader interpretation and application of the regulations within our processes.

Event Description

The field service engineer received a report from the site regarding a green splash screen on the mobile viewing station with an error message "could not load config file to ias" and the system wouldn't fully boot.

• 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: sam saleh ; 826 coal creek circle; louisville, CO 80027
• MDR Report Key: 6058127
• MDR Text Key: 58455954
• Report Number: 1723170-2016-03318
• 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: health professional,literatur
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 10/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2016
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/26/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2007
• 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