O-ARM 1000 IMAGING SYSTEM

MDR report key: 2884036 · Received December 21, 2012

Report

Report Number: 1723170-2012-00782
Event Type: Malfunction
Date Received: December 21, 2012
Date of Event: December 6, 2012
Report Date: December 6, 2012
Manufacturer: MEDTRONIC NAVIGATION, INC. (LITTLETON)
Product Code: OXO
PMA / PMN Number: K050996
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FL, US
Reporter Occupation: RADIOLOGIC TECHNOLOGIST

Narratives

Additional Manufacturer Narrative · 1

THE CORRECT FDA PRODUCT CODE WAS PROVIDED.

Additional Manufacturer Narrative · 1

A MEDTRONIC REPRESENTATIVE AT THE SITE PERFORMED 20 SPINS WITH VARIOUS SETTINGS; ISSUE COULD NOT BE DUPLICATED. MEDTRONIC ENGINEER REVIEW OF LOGS FOUND NO ERRORS OTHER THAN MISSING FILES FROM THE HANDSWITCH BEING RELEASED. THIS MAY INDICATE A FAULTY HANDSWITCH, BUT ROOT CAUSE CANNOT BE CONFIRMED. A PCBA BOARD WAS REPLACED ON THE SYSTEM AS THIS MAY RESOLVE THE ISSUE. NO FURTHER ISSUES REPORTED SINCE REPLACEMENT. SUSPECT BOARD HAS NOT BEEN RETURNED TO MANUFACTURER AS OF THE DATE OF THIS REPORT.

Additional Manufacturer Narrative · 1

THE SUSPECTED SYSTEM CONTROL BOARD HAS BEEN RECEIVED BY THE MANUFACTURER. A MEDTRONIC INVESTIGATION COULD NOT CONFIRM THE ALLEGED MALFUNCTION. THE SUSPECTED CONTROL BOARD WAS TESTED FOR 3 DAYS AND IT WORKED FINE.

Description of Event or Problem · 1

A SITE REPRESENTATIVE REPORTED THAT THE O-ARM 1000 IMAGING SYSTEM STOPPED ACQUIRING IMAGES MID-SPIN DURING A NAVIGATED SPINE PROCEDURE. THE SYSTEM WAS SHUT-DOWN AND RE-BOOTED, HOWEVER, THE ISSUE REPEATED ITSELF. THE SURGEON OPTED TO DISCONTINUE USE OF THE O-ARM AND COMPLETE THE PROCEDURE WITH THE USE OF A C-ARM. THERE WAS NO IMPACT ON PATIENT OUTCOME.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	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	58 YR