MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC O2; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number	BI70002000
Medical Device Problem Code	Application Program Freezes or Fails to Launch (4031)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient information provided as no patient was involved in this concern.Initial reporter not known from the site.The manufacturer representative went to the site to test the imaging system.The reported issue was confirmed and the mobile view station (mvs) pc cables were re-seated.The key board was returned to the manufacturer for evaluation.After visual/physical examination the reported issue was not confirmed.The keyboard was returned unused.No failures found.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding an imaging system.It was reported outside of a procedure that the keyboard on the demo imaging system was unresponsive to user input.No patient was present at the time of the event.

• Brand Name: O2
• Common Device Name: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 300 foster st; littleton MA 01460
• MDR Report Key: 8408550
• Report Number: 3004785967-2019-00397
• Device Sequence Number: 312313
• Product Code: OWB
• UDI-Device Identifier: 00643169980976
• UDI-Public: 00643169980976
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K151000
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: BI70002000
• Device Catalogue Number: BI70002000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2019
• Initial Report FDA Received Date: 03/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1