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 Break (1069); Poor Quality Image (1408); Device Displays Incorrect Message (2591)

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

Event Date 08/13/2018

Event Type  malfunction  

Manufacturer Narrative

Patient information was refused by the site.A medtronic representative went to the site to test the equipment.Testing revealed that the system was found to have a frame rate error.The mobile viewing station (mvs) interface cable was replaced.The imaging system then passed the system checkout and was found to be fully functional.The mvs interface cable has been returned to the manufacturer and is currently under analysis.

Event Description

Medtronic received information regarding an imaging system.It was reported that intra/peri-operatively during the select patient/acquire scans task of a sacroiliac and thoracolumbar procedure, the 2d images were very grainy and they were receiving a "frame grabber" error message.The site was able to capture 3d images.It was also reported that the site noticed visible damage to the umbilical cable where it plugs into the mobile viewing station (mvs).There was no delay to the procedure.There was no reported impact on patient outcome.

Manufacturer Narrative

The mobile view station (mvs) interface cable was returned to the manufacturer for analysis.Analysis found that the reported issue could be duplicated.The cable passed visual inspection, but failed testing due to line 8 and 7 being open.Analysis found that the reported event was related to an electrical issue.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: erika mitchellette ; navigation customer quality; 826 coal creek circle; louisville, CO 80027
• MDR Report Key: 7851801
• MDR Text Key: 119416549
• Report Number: 1723170-2018-04430
• 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,user f
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 11/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2018
• 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: 08/24/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/25/2011
• 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