MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC (LITTLETON) O1; IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE

Model Number	BI70000028120R
Medical Device Problem Code	Application Program Freezes or Fails to Launch (4031)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The system was serviced in the field.The wires to the front panel e stop switch were pinched by the front cover causing the molex connector to be intermittent when the gantry moved.Rerouted the front panel wiring harness to relieve tension on the molex connector.The system passed checkout.(b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding an imaging system being used outside of a procedure.It was reported that the imaging system was automatically going into e-stop as if the button was being pressed.However the button was not being pressed.This occurred multiple times while driving the system and during staff training.There was no patient present when this issue was identified.

• Brand Name: O1
• Common Device Name: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC (LITTLETON); 300 foster st; littleton MA 01460
• MDR Report Key: 9985706
• Report Number: 3004785967-2020-00486
• Device Sequence Number: 19982844
• Product Code: OXO
• UDI-Device Identifier: 00643169589292
• UDI-Public: 00643169589292
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K092564
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/22/2020

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: BI70000028120R
• Device Catalogue Number: BI70000028120R
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2020
• Initial Report FDA Received Date: 04/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1