MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC (LITTLETON) O-ARM O2 IMAGING SYSTEM; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number BI70002000

Device Problems No Display/Image (1183); Failure to Power Up (1476); Adverse Event Without Identified Device or Use Problem (2993); Application Program Freezes, Becomes Nonfunctional (4031)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/16/2021

Event Type  malfunction  

Event Description

Medtronic received information regarding an imaging system being used during a procedure.It was reported that the users were trying to take a spin, however, the system would not expose and it was beeping.Then, the mobile view station (mvs) was not powering on, the green led was not illuminated and they tried switching outlets with no resolve.They opened the back panel and one of the fuse lights was not illuminated.Use of the imaging system was aborted.There was no impact on patient outcome.Additional information was provided stating that this was a spinal procedure.The issue was able to be resolved by replacing the fuses and the procedure was able to continue.The procedure was delayed by more than one hour.Additional information was provided stating that the procedure was completed using an alternate imaging system.

Manufacturer Narrative

A medtronic representative went to the site to perform a system checkout.The fuses were replaced and the system passed checkout.If information is provided in the future, a supplemental report will be issued.

• Brand Name: O-ARM O2 IMAGING SYSTEM
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC (LITTLETON); 300 foster st; littleton MA 01460
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC (LITTLETON); 300 foster st; littleton MA 01460
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 13359492
• MDR Text Key: 289271195
• Report Number: 3004785967-2022-00057
• Device Sequence Number: 1
• Product Code: OWB
• UDI-Device Identifier: 00763000068097
• UDI-Public: 00763000068097
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200074
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/26/2022

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: Health Professional
• Device Model Number: BI70002000
• Device Catalogue Number: BI70002000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/06/2022
• Initial Date FDA Received: 01/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/29/2018
• 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: 78 YR
• Patient Sex: Female
• Patient Weight: 68 KG