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

Model Number	BI70002000
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient information provided as no patient was involved in this concern.Other relevant device(s) are: product id: b i71000176, serial/lot #: (b)(4).The manufacturer representative went to the site to test the imaging system.The reported issue was confirmed and they found no 96vdc coming out of the power conversion enclosure.They changed the enclosure.Then the system passed all tests and was up and running.(b)(4).The power conversion was returned to the manufacture for evaluation.After functional testing and visual/physical examination the reported issue was confirmed.The power conversion failed bench test.Diode d4 was shorted and transistor q3 readings were in both direction.(b)(4).The manufacture date was not available at the time of reporting.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 while transporting to the loading dock of the facility, the system lost control while the driving the system.No patient was present at the time of the event.Additional information was received stating that the system would not drive under motorized power, it needed to be in manual mode.The site was able to push the system. .

• Brand Name: O2
• Common Device Name: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC (LITTLETON); 300 foster st; littleton MA 01460
• MDR Report Key: 9531584
• Report Number: 3004785967-2019-02204
• Device Sequence Number: 18935270
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/30/2019

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: 11/22/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2019
• Initial Report FDA Received Date: 12/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1