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 Mechanical Problem (1384); Device Operates Differently Than Expected (2913); Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/17/2018

Event Type  malfunction  

Manufacturer Narrative

Patient information was unavailable from the site.A medtronic representative inspected the imaging system onsite and confirmed the issue.The door was slightly open and the rotor was in the wrong position.The door was repaired and the issue resolved.A full imaging system check-out was completed and all tests passed.Full system functionality was confirmed and the system was returned to service.No parts were replaced or returned to the manufacturer for evaluation.

Event Description

A medtronic representative reported that while in a spinal fusion procedure the imaging system would not open.Manual override was attempted but there was a 'clicking noise' and the door would not fully open.The system was rebooted and then stated, "initializing, please wait".E-stop was on the pendant and it was not possible to turn it off.The site attempted to manually open the door, but it was noted that at a point the wrench would no longer move and they could only see orange.The site again rebooted, attempted to open and do an override.The system would not open.The patient was removed from the imaging system during trouble shooting and the case was completed with a new imaging system.There was no impact on the patient outcome as a result of this issue.No additional information was provided.

Manufacturer Narrative

Additional information: additional procedure information received.

Event Description

Medtronic received information that there was at least a 30 minute delay to the procedure.

Manufacturer Narrative

Patient identifying number could not be obtained from the site.Patient information received.

• 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: stephanie riley ; navigation customer quality; 826 coal creek circle; louisville, CO 80027-9710 ; 7635267745
• MDR Report Key: 7248933
• MDR Text Key: 99269729
• Report Number: 1723170-2018-00586
• Device Sequence Number: 1
• Product Code: OXO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050996
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup
• Report Date: 09/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Radiologic Technologist
• Device Model Number: BI-700-00027-120
• Device Catalogue Number: 9732719
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2008
• 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: 73 YR
• Patient Weight: 83