O-ARM O2 IMAGING SYSTEM

Report

Report Number: 1723170-2016-01300
Event Type: Malfunction
Date Received: June 30, 2016
Date of Event: June 1, 2016
Report Date: July 27, 2016
Manufacturer: MEDTRONIC NAVIGATION, INC. (LITTLETON)
Product Code: OWB
PMA / PMN Number: K151000
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

PATIENT INFORMATION WAS UNAVAILABLE FROM THE SITE. NO PARTS WERE REPLACED OR RETURNED TO THE MANUFACTURER FOR EVALUATION. SITE PERSONNEL HAVE DECLINED TO PROVIDE ADDITIONAL INFORMATION. NO PARTS WERE REPLACED OR RETURNED FOR EVALUATION.

Additional Manufacturer Narrative · 1

ADDITIONAL INFORMATION: A MEDTRONIC REPRESENTATIVE REPORTED THAT THE PROCEDURE WAS A SPINE FUSION. THE ISSUE BEGAN WHEN THE SCAN SHOULD BE PERFORMED. THE ISSUE CAUSED A 5 MINUTE DELAY AND IMAGING TO BE DISCONTINUED. NAVIGATION WAS USED TO COMPLETE THE PROCEDURE WITH NO REPORTED IMPACT TO THE OUTCOME OF THE PATIENT. THE SOFTWARE INVESTIGATION FOUND THAT A PROBABLE CAUSE WAS UNABLE TO BE DETERMINED WITHOUT FURTHER INFORMATION SINCE THE ON-GOING INVESTIGATION PROVED TO BE INCONCLUSIVE BASED ON THE INFORMATION PROVIDED. THE SOFTWARE LOGS INDICATED SEVERAL INSTANCES OF THE FOLLOWING ERROR MESSAGE, ¿GENERATOR INTERFACE STATUS EVENT: GENERATOR INTERFACE ERROR. UNEXPECTED EXPOSE ENABLED (ERROR NUMBER=131072)¿, OCCURRED BEFORE THE SYSTEM WAS REBOOTED. AFTER REBOOT, THE SYSTEM WAS REHOMED AND OPERATING AS EXPECTED.

Description of Event or Problem · 1

A SITE REPRESENTATIVE REPORTED THAT THE IMAGING SYSTEM DISPLAYED "STAND ALONE MODE" ON THE PENDANT DURING A PROCEDURE. THE SYSTEM WAS REBOOTED AND THE SYSTEM THEN REQUIRED RE-HOMING. NO PATIENT IMPACT WAS REPORTED. NO ADDITIONAL DETAILS WERE PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
415707	O-ARM O2 IMAGING SYSTEM	INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM	OWB	MEDTRONIC NAVIGATION, INC. (LITTLETON)

Patients

Seq	Age	Sex	Outcome	Treatment
1	55 YR