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

Catalog Number BI70002000

Device Problems Electrical /Electronic Property Problem (1198); Device Inoperable (1663)

Patient Problem No Patient Involvement (2645)

Event Date 07/07/2017

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 and found the fuses on the mobile view station (mvs) had blown.The fuses were replaced and the issue was resolved.The blown fuses have not been received by the manufacturer for evaluation as they were discarded.A full imaging system check-out was completed following part replacement and all tests passed.Full system functionality was confirmed and the system was returned to service.

Event Description

A site representative reported that, monitor on the imaging system would not turn on.There was no delay to procedure as there was no patient present when this issue was observed.No other information has been provided.

• 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: stephanie riley ; attn:product quality experienc; 826 coal creek circle; louisville, CO 80027-9710 ; 7633987612
• MDR Report Key: 6761892
• MDR Text Key: 81682089
• Report Number: 1723170-2017-03146
• 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,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 08/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Radiologic Technologist
• Device Catalogue Number: BI70002000
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/24/2017
• 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