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

Model Number	BI70002000
Medical Device Problem Codes	Computer Software Problem (1112); Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient information provided as no patient was involved in this concern.H3: a medtronic representative went to the site to test the equipment.Testing revealed that the computer for the viewing station of the imaging system was replaced to restore functionality.The imaging system then passed the system checkout and was found to be fully functional.The computer for the viewing station of the imaging system has been received by the manufacturer for evaluation.However results are not available at this time.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that, while outside of a procedure, the viewing station of the imaging system would not initialize the operating system of the unit.Restarting the imaging system did not restore functionality.It was noted that remote desktop functionality could not be performed.The viewing station of the imaging system was then restarted with the interface (umbilical) cable connected and an error message appeared displaying "an error has occurred that may have damaged the system's integrity." a third restart was then performed with the interface (umbilical) cable disconnected.There was no patient present when this issue was identified as the site was preparing for a lab.
Additional Manufacturer Narrative
The analysis of the computer for the viewing station of the imaging system was completed by medtronic personnel.Testing found that computer could not load the operating system when powered on.It was noted that two screws were moving in the system and that all 4 hard drives were not seated upon arrival.If information is provided in the future, a supplemental report will be issued.

• Brand Name: O2 IMAGING SYSTEM
• Common Device Name: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC (LITTLETON); 300 foster st; littleton MA
• MDR Report Key: 7931397
• Report Number: 3004785967-2018-00018
• Device Sequence Number: 13931734
• Product Code: OWB
• UDI-Device Identifier: 00643169980976
• UDI-Public: 00643169980976
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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,Followup
• Report Date (Section B): 12/11/2018

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: 09/25/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2018
• Supplement Date Received by Manufacturer: 11/13/2018
• Initial Report FDA Received Date: 10/03/2018
• Supplement Report FDA Received Date: 12/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1