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

Model Number	BI70002000
Medical Device Problem Code	Failure to Run on Battery (1466)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A manufacturer representative went to the site to test the equipment.It was reported the power enclosure and batteries were re placed.The imaging system then passed the system checkout and was found to be fully functional.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 system needed new batteries.There was no patient present.
Additional Manufacturer Narrative
The batteries was returned to the manufacturer for analysis.Analysis found that the batteries failed bench test.All voltages from each battery and the total voltage measured were below specification.The batteries were bad and all fuses passed the continuity test.Analysis found that the reported event was related to a electrical issue.The power enclosure conversion was returned to the manufacturer for analysis.Analysis found that the part failed bench test and transistors q28 and q14 had shorted.Analysis found that the reported event was related to a electrical issue.If information is provided in the future, a supplemental report will be issued.

• Brand Name: O-ARM IMAGING SYSTEM O2
• Common Device Name: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 300 foster street; littleton MA 01460
• MDR Report Key: 8015353
• Report Number: 3004785967-2018-00206
• Device Sequence Number: 1131729
• Product Code: OWB
• UDI-Device Identifier: 00643169980976
• UDI-Public: 00643169980976
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 01/15/2019

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: 10/12/2018
• Initial Date Received by Manufacturer: 10/03/2018
• Supplement Date Received by Manufacturer: 10/03/2018
• Initial Report FDA Received Date: 10/29/2018
• Supplement Report FDA Received Date: 01/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1