NICVIEW 2.0 CAMERA

Description of Event or Problem

DURING A SITE VISIT DONE BY A NURSE REPORTED TO THE TECHNICIAN THAT A NICVIEW CAMERA HAD SPARKED AND ARCED. NO PATIENT OR USER HARMED BY THIS EVENT.

Additional Manufacturer Narrative

CUSTOMER WAS CONTACTED FOR FURTHER INFORMATION RELATING TO THIS ISSUE WHICH WAS REPORTED TO A THIRD-PARTY TECHNICIAN WHO WAS ON SITE FOR AN INSTALL TECHNICAL SERVICE SENT THE CUSTOMER AN EMAIL AND ALSO TRIED TO PHONE THE CUSTOMER 21 NOV & AGAIN 9 DEC. CASE WAS CLOSED AS THERE WAS NO RESPONSE. NO PATIENT OR USER WAS HARMED. RISK REVIEW: (B)(4) REV B - RISK ANALYSIS FOR NICVIEW 2.0 HAZARD 2.2. CAUSE - SHORT CIRSUIT DUE TO DAMAGED LOW VOLTAGE CABLE COMPONENTS, SUCH AS MICRO-USB CONNECTOR, CABLE, ETC. EFFECT - FIRE - FIRE - SMOKE INHALATION, SECOND DEGREE BURNS, THIRD DEGREE BURNS AND/OR ENVIRONMENTAL DAMAGE. RESIDUAL RISK - MODERATE. THE HAZARDS IDENTIFIED HAVE BEEN EVALUATED AND FOUND TO BE IN COMPLIANCE WITH A KNOWN STANDARD. AS NOTED IN QMS-000018 RISK MANAGEMENT SYSTEM PROCEDURE (SENSORY), HAZARDS THAT HAVE BEEN EVALUATED AND FOUND TO BE IN COMPLIANCE WITH KNOWN STANDARDS CAN BE PRESUMED TO BE CONSISTENT WITH AN ACCEPTABLE LEVEL OF RISK, YIELDING AN ACCEPTABLE RISK / BENEFIT TO THE PATIENT OR USER. RISK OUTWEIGHED BY BENEFIT OF USE OF DEVICE.

Description of Event or Problem

DURING A SITE VISIT DONE BY MERA, A NURSE REPORTED TO THE TECHNICIAN THAT A NICVIEW CAMERA HAD SPARKED AND ARCED. NO PATENT OR USER HARM CAUSED BY THIS EVENT.