NICVIEW 2.0 CAMERA

Description of Event or Problem

NICVIEW CAMERA STARTED TO SPARK AND SMOKE. THE NURSE UNPLUGED THE CAMERA AND BURNED HER HAND. THERE WAS A SPLIT IN ONE OF THE WIRES THAT COULD BE THE POTENTIAL CAUSE.

Additional Manufacturer Narrative

INITIAL REPORT REF NATUS COMPLAINT #: (B)(4) - RISK ANALYSIS FOR NICVIEW 2.0 HAZARD 2.2 CAUSE- SHORT CIRCUIT DUE TO DMAGED 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 CONSISTANT WITH AN ACCEPTABLE LEVEL OF RISK, YIELDING AN ACCEPTABLE RISK / BENEFIT TO THE PATIENT OR USER. RISK OUTWEIGHED BY BENEFIT OF USE OF DEVICE. CUSTOMER REPLACED NVARM 2 WITHA SPARE AND THEY WERE REQUESTED TO RETURN THE DEFECTIVE DEVICE FOR INVESTIGATION: MULTIPLE ATTEMPTS TO GET THE DEFECTIVE PART BACK. 12 SEP REQUEST FOR DEFECTIVE DEVICE TO BE RETURNED. 12 OCT REQUEST FOR DEFECTIVE DEVICE TO BE RETURNED. 22 DEC REQUEST FOR DEFECTIVE DEVICE TO BE RETURNED. JAN 19 REQUEST FOR DEFECTIVE DEVICE TO BE RETURNED. JAN 25 REQUEST FOR DEFECTIVE DEVICE TO BE RETURNED. FEB 03 REQUEST FOR DEFECTIVE DEVICE TO BE RETURNED. CASE WAS CLOSED AS THERE WAS NO RESPONSE.

Description of Event or Problem

NICVIEW CAMERA STARTED TO SPARK AND SMOKE. THE NURSE UNPLUGGED THE CAMERA AND BURNED HER HAND. THERE WAS A SPLIT IN ONE OF THE WIRES THAT COULD BE THE POTENTIAL CAUSE.

Additional Manufacturer Narrative

INITIAL REPORT REF NATUS COMPLAINT # (B)(4). (B)(4) - 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. CUSTOMER REPLACED NVARM 2 WITH A SPARE AND THEY WERE REQUESTED TO RETURN THE DEFECTIVE DEVICE FOR INVESTIGATION.