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

Catalog Number BI70002000

Device Problems Device Inoperable (1663); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 02/10/2017

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.Onsite investigation was preformed and the field representative discovered that blown fuses were the cause of the reported event.Replacement of the fuses resolved the issue.No further issues were reported.Replaced fuses were not returned to manufacturer for analysis, therefore, no findings are possible.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 the imaging system's mobile view station (mvs) line power light was not lit after plugging it into an outlet to store, the system and then the mvs powered off.There was no patient present when this issue was identified.

• 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: sam saleh ; 826 coal creek circle; louisville, CO 80027
• MDR Report Key: 6374360
• MDR Text Key: 68979076
• Report Number: 1723170-2017-00945
• 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: Health Professional
• Type of Report: Initial
• Report Date: 03/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2017
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2016
• 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