MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LITTLETON) O-ARM O2 IMAGING SYSTEM; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Catalog Number BI70002000

Device Problem Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138)

Patient Problem No Patient Involvement (2645)

Event Date 03/21/2018

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.A medtronic representative went to site to test the equipment.Representative reported that the mobile view station (mvs) would not boot intermittently and would not turn no and/to boot into bios screen.Representative replaced mobile view station (mvs) computer and computer power board.Issue resolved.A system checkout was performed and the hardware, software, and instruments passed the system checkout.The system was found to be fully functional.The suspect power board has been received by the manufacturer for evaluation but the results are not available yet.The computer has not been received by the manufacturer for evaluation.

Event Description

A medtronic representative reported that while outside of procedure, when the imaging system was turned on, it would not boot past the bios screen and would not complete the boot process.Representative tried manually turning it off but the system would not shut down from the button and the lights on the front kept flashing.The system was unplugged from the wall until it shut down, after which it booted with no difficulty.There was no patient present at the time of the issue.

Manufacturer Narrative

The analysis of the power board for the viewing station of the imaging system was completed by medtronic personnel.The power board was found to be fully functional with no problem found.The reported event could not be duplicated by medtronic personnel.The computer for the viewing station of the imaging system was returned to the manufacturer for analysis.The computer was found to be fully functional with no problem found.The reported event could not be duplicated by medtronic personnel.

• Brand Name: O-ARM O2 IMAGING SYSTEM
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• 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 ; 7208902515
• MDR Report Key: 7423262
• MDR Text Key: 105404379
• Report Number: 1723170-2018-01596
• Device Sequence Number: 1
• Product Code: OWB
• UDI-Device Identifier: 00643169639683
• UDI-Public: 00643169639683
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151000
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 07/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Radiologic Technologist
• Device Catalogue Number: BI70002000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/29/2016
• 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