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 Computer Software Problem (1112); Communication or Transmission Problem (2896); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/20/2017

Event Type  malfunction  

Manufacturer Narrative

A phone representative answered the sites question regarding the imaging system.It was reported that when the manufacturer representative (rep) looked at the ip settings they realized the ip setting for the navigation system on the imaging system were incorrect.Once the issue was fixed the system worked as intended.

Event Description

Medtronic received information regarding an imaging system being used in a cranial resection.It was reported that the imaging system and the navigation system were not communicating even though they were connected to each other.During trouble shooting the site found that the ip setting for the navigation system were incorrect.The procedure was delayed 10 minutes.No impact on patient outcome.

Manufacturer Narrative

Correction to the initial reporter.

Manufacturer Narrative

No system checkout was performed and no analysis was completed on the system.Device not returned.

• 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: stephanie riley ; navigation customer quality; 826 coal creek circle; louisville, CO 80027-9710 ; 7635267745
• MDR Report Key: 7602567
• MDR Text Key: 111678875
• Report Number: 1723170-2018-02783
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/20/2017
• Initial Date FDA Received: 06/14/2018
• Supplement Dates Manufacturer Received: 09/17/2018; 09/17/2018
• Supplement Dates FDA Received: 09/17/2018; 09/17/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/23/2009
• 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