MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC (LITTLETON) O-ARM; IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE

Model Number BI70000028120

Device Problems Overheating of Device (1437); Smoking (1585)

Patient Problem No Patient Involvement (2645)

Event Date 03/09/2020

Event Type  malfunction  

Manufacturer Narrative

A medtronic representative went to the site to test the equipment.Testing revealed the battery appeared to have overheated due to corrosion of battery terminal causing resistance/poor contact.All 38 system batteries, tray 4, contact terminals and wiring were replaced.The system then passed the system checkout and was found to be fully functional.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding an imaging system being used outside of a procedure.It was reported that the image acquisition system (ias) had a thermal event.The biomedical engineer pulled out the middle battery on the top tray which was overheating to resolved the issue.This took place in a storage room.There was no patient involved.

• Brand Name: O-ARM
• Type of Device: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC (LITTLETON); 300 foster st; littleton MA 01460
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC (LITTLETON); 300 foster st; littleton MA 01460
• Manufacturer Contact: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 9897990
• MDR Text Key: 185524651
• Report Number: 3004785967-2020-00424
• Device Sequence Number: 1
• Product Code: OXO
• UDI-Device Identifier: 00643169353428
• UDI-Public: 00643169353428
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092564
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 03/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BI70000028120
• Device Catalogue Number: BI70000028120
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/09/2020
• Initial Date FDA Received: 03/30/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/22/2014
• 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