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 Computer Software Problem (1112); Electrical /Electronic Property Problem (1198)

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

Event Date 05/14/2018

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.Udi not available at the time of filing.A medtronic representative went to the site to test the equipment.Testing revealed that the mobile view station (mvs) was replaced.Systems checkout was performed and system was functioning as intended.

Event Description

Medtronic received information regarding an imaging system outside of procedures.On (b)(6),the mvs suddenly rebooted and afterwards became unresponsive.There was no patient present in either case.

Manufacturer Narrative

The computer for the viewing station of the imaging system was returned to the manufacturer for analysis.The computer was found to be fully functional with no problem found.Unrelated to functionality, scratches were noted on the computer housing.The reported event could not be duplicated by medtronic personnel.

Manufacturer Narrative

Additional information: unique device identification (udi) provided.

• 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: peter verhey ; navigation customer quality; 826 coal creek circle; louisville, CO 80027-9710
• MDR Report Key: 7573503
• MDR Text Key: 110219611
• Report Number: 1723170-2018-02544
• Device Sequence Number: 1
• Product Code: OXO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K050996
• 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
• Report Date: 09/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/14/2018
• Initial Date FDA Received: 06/06/2018
• Supplement Dates Manufacturer Received: 08/07/2018; 08/31/2018
• Supplement Dates FDA Received: 08/28/2018; 09/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2010
• 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