MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LITTLETON) O-ARM 1000 IMAGING SYSTEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number BI-700-00027-120

Device Problems Melted (1385); Smoking (1585)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/05/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(6) 2015 a medtronic representative performed an imaging system check-out, all areas passed except mechanical test failed.Power cord had a loose prong and when connected to the power outlet it started to smoke, melting off the prong.Replaced power cable and performed a system check.O-arm operational.Issue resolved.- return requested.Replacement mvs power cord shipped to site.No parts have been received by manufacturer for analysis.

Event Description

A medtronic representative reported an imaging system mobile viewing system (mvs) plug started smoking and one of the prongs melted off.No further details regarding the damage, or how it occurred, were provided.There was no patient present when this issue was identified.

Manufacturer Narrative

Suspect power cord analysis: confirmed reported problem "power cord had a loose prong making a bad connection melting a prong off." molded plug white blade was loose, system was still used, resulting in a melted white blade.Electrical malfunction caused event.

• Brand Name: O-ARM 1000 IMAGING SYSTEM
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• 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: catherine eaton ; 826 coal creek circle; louisville, CO 80027 ; 7208902092
• MDR Report Key: 5050608
• MDR Text Key: 25459477
• Report Number: 1723170-2015-01060
• Device Sequence Number: 1
• Product Code: OXO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050996
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Report Date: 10/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Radiologic Technologist
• Device Model Number: BI-700-00027-120
• Device Catalogue Number: 9732719
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/06/2012
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1