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

Catalog Number BI70002000

Device Problem Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/26/2018

Event Type  malfunction  

Manufacturer Narrative

A medtronic representative went to site to test the equipment.Representative reported that the voltage was not coming out of the power conversion board.Representative replaced power conversion board and updated firmware to resolve the issue.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 board has been received by the manufacturer for evaluation but the results are not available yet.

Event Description

A site representative reported that during spinal fusion procedure, the pendant of the imaging system displayed "initialization please wait".Rebooting the image acquisition system (ias) and mobile view station (mvs) while the umbilical was disconnected and then reconnecting the image acquisition system (ias) and mobile view station (mvs) did not resolve the issue.The procedure was completed without the use of imaging.There was a delay of less than 1 hour.No known impact on patient outcome.

Manufacturer Narrative

The power conversion enclosure was returned to the manufacturer for evaluation.Testing found that the voltage input was at zero on the board.It was noted that the indicator test did not pass.

• 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: peter verhey ; navigation customer quality; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902515
• MDR Report Key: 7430741
• MDR Text Key: 105656185
• Report Number: 1723170-2018-01634
• 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,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2018
• 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: 04/12/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/16/2017
• 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
• Patient Age: 69 YR
• Patient Weight: 75