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

Catalog Number BI70002000

Device Problems Computer Software Problem (1112); Electrical /Electronic Property Problem (1198); Device Emits Odor (1425)

Patient Problem No Patient Involvement (2645)

Event Date 06/12/2016

Event Type  malfunction  

Manufacturer Narrative

A medtronic representative inspected the imaging system on-site.It was found that the power conversion enclosure had failed.The power conversion enclosure was replaced.All battery-trays were also replaced.The system functions were then checked, and all tests passed.The power conversion enclosure and battery trays have not been returned to the manufacturer for evaluation.A software investigation was also completed.This investigation determined that the reported behavior is a known anomaly.This anomaly is tracked through an anomaly tracking database and references to this instance have been added.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.

Event Description

A medtronic representative reported that while driving the imaging system down a 15 meter long ramp, the system made a loud "bang" sound and there was a burning smell.This occurred outside of any patient involvement.No additional details were provided.

Manufacturer Narrative

Correction: original aware date was 06/13/2016.Additional information: the power conversion enclosure was received by the manufacturer.During part analysis there was a confirmed open failure with the power conversion enclosure.

• 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: jasmine birlew ; attn:product quality experienc; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902447
• MDR Report Key: 5779033
• MDR Text Key: 49140430
• Report Number: 1723170-2016-01368
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• PMA/PMN Number: K151000
• 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
• Report Date: 05/25/2017

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: Medical Equipment Company Technician/Representative
• Device Catalogue Number: BI70002000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/12/2016
• Initial Date FDA Received: 07/08/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2016
• 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