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

Catalog Number BI70002000

Device Problems Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Electrical /Electronic Property Problem (1198); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 12/11/2017

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.A medtronic representative inspected the imaging system onsite and found the motions not initializing.The problem was tracked to a loss of 24 volt dc to the brakes in the power conversion module.The power conversion module was replaced and the issue resolved.A full imaging system check-out was completed following part replacement and all tests passed.Full system functionality was confirmed and the system was returned to service.The suspect part has been returned to the manufacturer for evaluation, however, no results are available at this time.

Event Description

A medtronic representative reported that while outside of a procedure, the imaging system was not initializing.The representative attempted to trouble shoot the mobile view station (mvs) desktop, but the system was down.

Manufacturer Narrative

The enclosure power conversion was returned to the manufacturer for analysis.Analysis found that there was a loss of 24 volt dc to brakes in the power conversion module.There was a transistor found to be shorted.Analysis found that the reported event was related to an electrical issue.

• 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: pa chia vue ; attn:product quality experienc; 826 coal creek circle; louisville, CO 80027-9710 ; 7635267745
• MDR Report Key: 7169195
• MDR Text Key: 96608580
• Report Number: 1723170-2018-00074
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2018
• 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: 01/02/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/16/2016
• 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