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); Intermittent Loss of Power (4016)

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

Event Date 06/21/2018

Event Type  malfunction  

Manufacturer Narrative

Patient information was unavailable from the site.No parts have been returned to the manufacturer for analysis.A medtronic representative went to the site to test the equipment.Testing revealed that the relay and varistor were causing the motor to stop prematurely.Replaced the relay and varistor and the system regained functionality.Systems checkout was performed and system was functioning as intended.

Event Description

Medtronic received information regarding an imaging device being used for a sacroiliac and thoracolumbar procedure.It was reported that the system was not taking a full 3d spin and would stop after about a quarter or half spin was captured.The system was also not raising all the way up.There was no patient impact reported.

Manufacturer Narrative

Additional information: it was determined there was an unconfirmed accidental radiation occurrence due to early termination of acquisition.No defect in an electronic product or failure to comply per 21 cfr 1003 was discovered.The investigation concluded that the issue was due to hardware.Relay and varistor components replaced to resolve.Number of people exposed: 1 - patient total number of people in or unknown.Estimated absorbed or effective dose information is not available.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: jack edell ; navigation customer quality; 826 coal creek circle; louisville, CO 80027
• MDR Report Key: 7693652
• MDR Text Key: 114153339
• Report Number: 1723170-2018-03491
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 03/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2018
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/13/2019
• 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