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

Catalog Number BI70002000

Device Problems Thermal Decomposition of Device (1071); Device Emits Odor (1425)

Patient Problem No Patient Involvement (2645)

Event Date 10/14/2015

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.This was discovered outside of a procedure so no patient impact.Return requested.Replacement enclosure power conversion shipped to site 10/14/2015.No parts have been received by manufacturer for analysis.Return requested.Replacement pcba gen dgtl mtn cnt shipped to site 10/29/2015.No parts have been received by manufacturer for analysis.On 11/04/2015 a medtronic representative performed a navigation system check-out, imaging modalities, cable grade, safety inspection and software areas passed.Mechanical test failed.Power conversion failed.Replaced power conversion enclosure.Issue resolved.System performed as intended.

Event Description

A medtronic representative received a report from a site of a burning smell coming from the gantry after driving the imaging system down a steep hill.In trouble-shooting, the medtronic representative removed the image acquisition system (ias) rear cover, powered on the imaging system, and a flame appeared through the upper fans on the right side of the generator cabinet.No further details regarding the damage were provided.There was no patient present when this issue was identified.

Manufacturer Narrative

The kit svc (b)(4) pcba gen dgtl mtn cnt was returned unused.The power conversion enclosure is still under analysis.

Manufacturer Narrative

Medtronic investigation of returned suspect power conversion enclosure finds that the regenerative electrical energy from driving down the steep slope could not be adequately absorbed by the power conversion box.This caused overload of power resistor r97, resulting in the symptoms observed.The protective mechanisms in the design operated as intended, containing the failing component.The reported event was confirmed to be caused by an electrical failure mode due to the power resistor r97.

Manufacturer Narrative

Per safety risk management review of the reported incident, the overall risk increased for thermal and mechanical safety which per procedure required a capa investigation to be opened.Per further engineering review associated with the capa, the cause was found to be that the power conversion board was not designed to absorb the amount of regenerative power that is continuously created by driving down a long ramp.470 watts can be absorbed by power conversion board for a short amount of time, sufficient for the machine to stop on a level surface from the full speed.A new active clamp assembly is being developed for addition to the o2 design.It will be inserted between the existing power conversion assembly and the digital motion control board which will not require changes to either of those components, and at a minimum will robustly absorb the regenerative energy produced when the o2 is driven down a 5 degree ramp.In addition, it was recommended that the high level design requirements be updated to identify the duration of downhill driving time for normal use.

• 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: amos jarrette ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902082
• MDR Report Key: 5215541
• MDR Text Key: 30971792
• Report Number: 1723170-2015-01376
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• Reporter Country Code: SG
• 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,Followup,Followup
• Report Date: 03/11/2016

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: Radiologic Technologist
• Device Catalogue Number: BI70002000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/14/2015
• Initial Date FDA Received: 11/10/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 12/16/2015; 02/17/2016; 03/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/14/2015
• 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