NEUROCOM EQUITEST
Received Jul 31, 2018 · Event occurred Jun 29, 2018
Report 3018859-2018-00135 · MDR key 7737403
Device
Product problems
- Application Program Freezes or Fails to Launch
- Application Program Freezes or Fails to Launch
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
NATUS TECHNICAL SERVICE CONFIRMED THAT THE SYSTEM WAS FROZEN WHILE TROUBLESHOOTING THE ISSUE REMOTELY WITH THE COMPLAINANT. NATUS TECHNICAL SERVICE WALKED THE COMPLAINANT THROUGH TURNING OFF THE DYNAMIC PLATFORM AND DISCONNECTING POWER TO THE COMPUTER. AFTER LETTING THE SYSTEM REST FOR AT LEAST A MINUTE, POWER WAS RECONNECTED. THE SYSTEM THEN OPERATED CORRECTLY AND THE FAILURE COULD NO LONGER BE DUPLICATED. NATUS TECHNICAL SERVICE ADVISED THE COMPLAINANT TO CONTINUE MONITORING THE SYSTEM AND CONTACT NATUS SHOULD THE ISSUE REOCCUR. BECAUSE THE ISSUE RESOLVED ITSELF AFTER CYCLING POWER TO THE SYSTEM, THE CAUSE OF THE ISSUE COULD NOT BE DETERMINED.
Description of Event or Problem
IT WAS REPORTED TO NATUS THAT DURING A GAZE STABILIZATION TEST (GST), THE SMART EQUITEST SYSTEM FROZE. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR ENVIRONMENTAL/SAFETY CONCERNS.