FDA Adverse Event Malfunction Summary report: N

O-ARM 1000 IMAGING SYSTEM

MDR report key: 3822014 · Received May 20, 2014

Report

Report Number: 1723170-2014-00591
Event Type: Malfunction
Date Received: May 20, 2014
Date of Event: April 25, 2014
Report Date: April 25, 2014
Manufacturer: MEDTRONIC NAVIGATION, INC. (LITTLETON)
Product Code: OXO
PMA / PMN Number: K050996
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CO, US
Reporter Occupation: BIOMEDICAL ENGINEER

Narratives

Additional Manufacturer Narrative · 1

A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. SHE WAS ABLE TO REPRODUCE THE REPORTED EVENT. THE COMPUTER WOULD NOT BOOT. THE COMPUTER WAS REPLACED, THE SYSTEM WAS REBOOTED SEVERAL TIMES, AND SEVERAL 3D SPINS, FLUORO AND BOOST SCANS WERE TAKEN. THE IMAGING SYSTEM WAS CALIBRATED AND CONNECTED TO THE NAVIGATION SYSTEM AND FOUND TO BE FULLY FUNCTIONAL. THE COMPUTER WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE COMPUTER WOULD NOT BOOT UP AND THE CONFIG FILE WAS FOUND TO BE EMPTY. THE REPORTED EVENT WAS CONFIRMED TO BE CAUSED BY A SOFTWARE PROBLEM WITH THE COMPUTER.

Description of Event or Problem · 1

A SITE REPRESENTATIVE REPORTED THAT THE IMAGE ACQUISITION SYSTEM (IAS) WAS DISPLAYING "SYSTEM BOOTING PLEASE WAIT" ON THE PENDENT DURING A LUMBAR FUSION SURGERY. HE ATTEMPTED TO RESTART THE SYSTEM 3 TIMES AND RE-SEATED THE UMBILICAL CABLE WITHOUT RESOLUTION. HE ATTEMPTED TO RESTART THE IAS APPLICATION BUT WAS UNABLE TO LAUNCH THE SOFTWARE AND RECEIVED AN ERROR MESSAGE. THIS CAUSED A SURGICAL DELAY OF APPROXIMATELY 1 HOUR. THE SURGEON USED A C-ARM WITH A POINTMERGE REGISTRATION TO FINISH THE SURGERY. THERE WAS NO IMPACT TO THE OUTCOME OF THE PATIENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
300434	O-ARM 1000 IMAGING SYSTEM	IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE	OXO	MEDTRONIC NAVIGATION, INC. (LITTLETON)	BI-700-00027-120

Patients

Seq	Age	Sex	Outcome	Treatment
1	45 YR