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

Catalog Number BI70002000

Device Problem Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/20/2017

Event Type  malfunction  

Manufacturer Narrative

On 6/23/2017 a medtronic field service engineer visited the site to test the system: upon inspection, fse was not able to duplicate the reported issue.Logs confirmed recoverable error 134 (5vdc out of tolerance); old ps1 was @ 4.8vdc; replaced ps1 and adjusted to within tolerance @5.11; batteries tested good with stack checker; logs gathered and attached to case for further analysis ; system checkout passed.Clinical specialist verified accuracy and found the s7 camera to be dirty with a greasy film on the right lens.After cleaning, the o-arm and s7 were able to function as normal.Accuracy was within limits.Systems fully functional.Issue resolved.

Event Description

A site radiology tech (rt) called to report that during a spinal surgery, the image acquisition system (ias) began beeping a few minutes after being on.They were half way through the case and the o-arm stopped exposing.Reboot resolved the issue, they were able to take a full spin and several thereafter.No harm to patient.Delay less than an hour.Surgery completed with use of the o-arm system.

Manufacturer Narrative

The software investigation found that the reported event was unrelated to a software issue.Log analysis found that when the generator error occurred, the 3d image acquisition was ceased due to the error being received.The software functioned as designed.

Manufacturer Narrative

The event reported in this 3500a also represents a potential accidental radiation occurrence (aro) per 21 cfr 1002.20(a).Per 21 cfr 1002.20(c), this event is being reported under part 803.Supplemental aro information is as follows: location of aro: (b)(6).Number of persons exposed: 1.Number of persons adversely affected: 0.Actions taken to control, correct, or eliminate: see narrative above and/or previous mdr submissions.

Manufacturer Narrative

The power supply was returned to the manufacturer for analysis.The supply was found to be fully functional with no problem found.The reported event could not be duplicated by medtronic personnel.

• 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 ; 7208902092
• MDR Report Key: 6725973
• MDR Text Key: 80496886
• Report Number: 1723170-2017-02989
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151000
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Radiologic Technologist
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Radiologic Technologist
• Device Catalogue Number: BI70002000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2016
• 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
• Patient Age: 54 YR
• Patient Weight: 57