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

Model Number	BI70002000
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A manufacturer representative went to the site to test the equipment.The power conversion enclosure, charger enclosure, and batteries were replaced.The imaging system then passed the system checkout and was found to be fully functional.The power conversion enclosure was returned for analysis, and through testing the reported complaint was confirmed.The power conversion enclosure failed the bench test.Transistors q28, q1 and q14 were found shorted.It was determined that there was an electrical failure with the power conversion enclosure.The batteries and charger enclosure were returned to the manufacturer but were under analysis at the time of filing.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding an imaging device being used outside of a procedure.It was reported that when un-crating the imaging system at the account, it was found that the mobile view station (mvs) would power on but the image acquisition system (ias) would not.The site stated that there was no blue power light from the ias.There was no patient present when this issue was identified.
Additional Manufacturer Narrative
Device evaluation: analysis was completed for both sets of batteries that were returned as well as the charger enclosure.Through visual/physical examination and performance testing of the batteries, the reported complaint was confirmed.Visual inspection showed scuffs and scratches consistent with normal use.Bench testing was performed at normal room temperature.There was no expansion, leaking, fusing or corrosion.All battery trays failed bench testing, however.All batteries measured lower than 6 vdc.It was noted that all fuses passed.It was determined that the batteries were at the end of their lifespan.The reported complaint was also confirmed through visual/physical examination and functional testing of the charger enclosure.Visual inspection confirmed that the housing was dented on the edge.The part was installed on a test system; the system did not charge and the image acquisition system (ias) was unable to power on.The charger enclosure was determined to be defective.Analysis determined that there was an electrical failure with the returned batteries and charger enclosure.Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the fda 3500a form and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.Medtronic objects to the use of these words and others like it because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: O-ARM O2 IMAGING SYSTEM
• Common Device Name: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC (LITTLETON); 300 foster st; littleton MA 01460
• MDR Report Key: 8282723
• Report Number: 3004785967-2019-00147
• Device Sequence Number: 167849
• Product Code: OWB
• UDI-Device Identifier: 00643169980976
• UDI-Public: 00643169980976
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 03/07/2019

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: 01/11/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2019
• Supplement Date Received by Manufacturer: 02/13/2019
• Initial Report FDA Received Date: 01/28/2019
• Supplement Report FDA Received Date: 03/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1