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

Catalog Number BI70002000

Device Problems Device Emits Odor (1425); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 10/18/2016

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.A medtronic representative inspected the imaging system on-site.It was found that driving the imaging system down a steeper than normal crate ramp caused the power conversion assembly to become damaged.The assembly was replaced and the issue was resolved.The damaged assembly has not been received by the manufacturer for evaluation.A software investigation was also completed.The software investigation found that the reported event was related to a software issue.This issue was documented in a medtronic navigation software anomaly tracking database.A full imaging system check-out was completed and all tests passed.Full system functionality was confirmed and the system was returned to service.

Event Description

A medtronic representative reported that when uncrating the imaging system and driving it down the crate ramp, a burning smell was detected.The user stopped driving the system and attempted to boot the system up.The motion controls would then not initialize and the system would not drive.There was no patient present when this issue was identified.

Manufacturer Narrative

The power conversion enclosure was returned to the manufacturer for evaluation.Testing found that two diodes were open on the circuit board.The testing confirmed the reported issue as no voltage could be supplied.This confirmed an electrical failure due to the open diodes.

• 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 ; 826 coal creek circle; louisville, CO 80027 ; 7208902439
• MDR Report Key: 6105799
• MDR Text Key: 60033222
• Report Number: 1723170-2016-02962
• Device Sequence Number: 1
• Product Code: OWB
• 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
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 03/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Medical Equipment Company Technician/Representative
• Device Catalogue Number: BI70002000
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2016
• 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