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

Catalog Number BI70002000-G30

Device Problems Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Device Operates Differently Than Expected (2913)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 07/18/2017

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.Testing was not performed as the issue was resolved at the time of the event.No parts were replaced.No parts have been received by manufacturer for evaluation.

Event Description

A site representative reported that while outside of a procedure, the imaging system remained in initialization.Please wait for 20 minutes.Rebooting the system resolved the issue.There was no patient present at the time of the issue.

Manufacturer Narrative

Correction: coding updated to proper value.

• Brand Name: O-ARM O2 IMAGING SYSTEM
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• 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 ; attn:product quality experienc; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902515
• MDR Report Key: 6789973
• MDR Text Key: 82575173
• Report Number: 1723170-2017-03304
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K151000
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 08/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Radiologic Technologist
• Device Catalogue Number: BI70002000-G30
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2016
• 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