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

Catalog Number BI70002000-G27

Device Problems Device Inoperable (1663); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 06/01/2018

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.Unique device identifier (udi) is unavailable.Device manufacture date is unavailable.No parts have been received by the manufacturer for evaluation.

Event Description

Medtronic received information that, while outside of a procedure, the imaging system pendant displayed that the viewing station of the imaging system was disconnected.It was noted that the imaging system would not complete start up due to the generator.Restarting the imaging system did not restore functionality.Initial troubleshooting found that the imaging system would not shut down and that the generator was not loading the firmware properly.There was no patient present when this issue was identified.No additional information was provided.

Manufacturer Narrative

A software investigation analysis was initiated to determine the probable cause of the issue through review of the reported issue.Analysis found that the issue is due to a hardware malfunction.Analysis found that the software functioned as designed.

Manufacturer Narrative

A medtronic representative went to the site to test the equipment.Testing revealed that the power conversion enclosure and isolated generator control board.The imaging system then passed the system checkout and was found to be fully functional.

Manufacturer Narrative

The enclosure power conversion was returned to the manufacturer for analysis.Analysis found that the enclosure power conversion failed bench test and the transistor was open.Analysis found that the reported event was related to a electrical issue.The pcba generator was returned to the manufacturer for analysis.Analysis found that the standalone pcb passed bench test and voltage was present.All leds were functioning normally and fans were operating correctly.No fault found.

• 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: prashanth gali ; navigation customer quality; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902515
• MDR Report Key: 7648123
• MDR Text Key: 112717327
• Report Number: 1723170-2018-03055
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K151000
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Radiologic Technologist
• Device Catalogue Number: BI70002000-G27
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/14/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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