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

Catalog Number BI70002000

Device Problems Electrical /Electronic Property Problem (1198); Device Inoperable (1663)

Patient Problem No Patient Involvement (2645)

Event Date 09/18/2017

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.A medtronic representative went to site to test the equipment.Representative reported that fuses were replaced and replaced power conversion due to lack of 96v power for motion.A system checkout was performed and the hardware, software, and instruments passed the system checkout.The system was found to be fully functional.The suspect power conversion has been received by manufacturer for evaluation but results are not yet available.The suspect fuses have not been received by manufacturer for evaluation.

Event Description

A medtronic representative reported that while outside of procedure the image acquisition system (ias) of the imaging system would not turn when pressing on switch but mobile view station (mvs) turned on.Representative mentioned that battery indicator lights were full.Disconnecting the umbilical cable did not resolve the issue.There was no patient present at the time of issue.

Manufacturer Narrative

The enclosure power conversion was returned to the manufacturer for analysis.Analysis found that the power conversion assembly failed its functional test.The transistors were found to have shorted.There was an electrical issue identified.

• Brand Name: O-ARM O2 IMAGING SYSTEM
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LITTLETON); 300 foster street; littleton MA 01460
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC. (LITTLETON); 300 foster street; littleton MA 01460
• Manufacturer Contact: pa chia vue ; attn:product quality experienc; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902515
• MDR Report Key: 6952679
• MDR Text Key: 90397455
• Report Number: 1723170-2017-04147
• Device Sequence Number: 1
• Product Code: OWB
• UDI-Device Identifier: 00643169639683
• UDI-Public: 00643169639683
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151000
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 05/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Radiologic Technologist
• Device Catalogue Number: BI70002000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/20/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1