MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LITTLETON) O-ARM 1000 IMAGING SYSTEM; IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE

Model Number BI-700-00027-120

Device Problems Electrical /Electronic Property Problem (1198); Failure to Fire (2610); Communication or Transmission Problem (2896)

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

Event Date 07/24/2018

Event Type  malfunction  

Manufacturer Narrative

Patient information not provided due to chile patient privacy regulations.No parts have been returned to the manufacturer for analysis.

Event Description

Medtronic received information regarding an imaging device being used for a sacroiliac and thoracolumbar procedure.The issue occurred intraoperatively during the select patient/acquire scans task and delayed the surgery by less than one hour.It was reported that the customer reported problems during the booting process.There was a three-status-bars x-ray going up displayed but it did not finish.The customer rebooted 2 or 3 times before the system booted correctly.The same issue occurred in the middle of the procedure and at the end.The manufacturer representative could not reproduce the fail.The customer reported that in some moments there was difficulty pressing some pendant buttons.There were some errors related with communication and there was an error 33 (no communication between the generator and the pc) the manufacturer representative performed a clean of ethernet connector between the ethernet switch dispositive and all the connection.The surgery was completed with navigation and there was no impact on patient outcome.

Manufacturer Narrative

The hand switch for the imaging system was returned to the manufacturer for evaluation.Testing found that the hanger on the unit was damaged.Otherwise, the unit was found to be fully functional.If information is provided in the future, a supplemental report will be issued.

• Brand Name: O-ARM 1000 IMAGING SYSTEM
• Type of Device: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE
• 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: maxwell roth ; attn:product quality experienc; 826 coal creek circle; louisville, CO 80027-9710
• MDR Report Key: 7793334
• MDR Text Key: 117478629
• Report Number: 1723170-2018-04102
• Device Sequence Number: 1
• Product Code: OXO
• Combination Product (y/n): N
• PMA/PMN Number: K050996
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BI-700-00027-120
• Device Catalogue Number: 9732719
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/24/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/22/2013
• 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