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 Problem Computer Software Problem (1112)

Patient Problem No Patient Involvement (2645)

Event Date 07/09/2018

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.No parts have been returned to the manufacturer for analysis.

Event Description

Medtronic received information regarding an imaging system being used outside of a procedure.It was reported that the mobile viewing station (mvs) boots well, but the image acquisition system (ias) was unresponsive and showing "initializing system." the fan never finished the initialization, so the site attempted to unplug it and it would still not go past the initializing screen.Site added that after unplugging and reconnecting the cable, the mvs was beeping loudly and did not go past the start windows screen.Site then restarted the system and ias was not going past the initializing screen and the mvs was beeping.Site was unable to "open image" and the fan loading on the scanner was not finished so the site couldn't do any type of scan.There was no patient present during this event.

Manufacturer Narrative

A software investigation analysis was initiated to determine the probable cause of the issue through review of the reported issue.Analysis found that the reported issue was unrelated to the software of the imaging system.Analysis found that the software functioned as designed.

• 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: peter verhey ; navigation customer quality; 826 coal creek circle; louisville, CO 80027-9710
• MDR Report Key: 7737241
• MDR Text Key: 115647873
• Report Number: 1723170-2018-03775
• Device Sequence Number: 1
• Product Code: OXO
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K050996
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 08/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BI-700-00027-120
• Device Catalogue Number: 9732719
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/30/2009
• 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