NICVIEW 2.0 CAMERA

Description of Event or Problem

CORD THAT PLUGS INTO THE USB PORT WAS FRAYED AND SPARKED WHEN UNIT WAS PLUGGED IN. WHEN ATTEMPTING TO REMOVE CORD FROM USB PORT, CORD BROKE IN HALF. ADDITIONALLY, NO PATIENT OR USER HARM REPORTED.

Additional Manufacturer Narrative

NO SIGNIFICANT HEALTH IMPACT OR CONSEQUENCE. NV 2.0 ARM (PART NUMBER NVARM2) IS SENT TO THE CUSTOMER. ADDITIONALLY, THE CUSTOMER HAS RETURNED THE DEFECTIVE DEVICE TO THE MANUFACTURER. DURING THE INVESTUGATION, IT IS DETERMINED THAT IT APPEARS THIS MAY BE DUE TO IMPROPER USE OR POTENTIAL MISUSE OF THE SYSTEM (USE ERROR). USER ERROR- "EXTREME MECHANICAL DAMAGE CAUSES AN ELECTRICAL SHORT, LEADING TO DEFORMATION OF THE PLASTIC OVERMOLD ON THE MICRO-USB CONNECTOR AND REPORTED SPARKING NEAR THE CONNECTOR." ACCEPTABLE RISK OF THERMAL HAZARD. RISK RATING: (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. SEVERITY -11 WHICH DEFINES, RISK CONTROL MEASURE(S) MUST BE APPLIED TO LOWER THE RISK IF POSSIBLE AND VERIFIED AS BEING EFFECTIVE. THE HAZARDS IDENTIFIED HAVE BEEN EVALUATED AND FOUND TO BE IN COMPLIANCE WITH A KNOWN STANDARD. AS NOTED IN RISK MANAGEMENT SYSTEM PROCEDURE (QMS-000018), 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.

Description of Event or Problem

CORD THAT PLUGS INTO THE USB PORT WAS FRAYED AND SPARKED WHEN UNIT WAS PLUGGED IN. WHEN ATTEMPTING TO REMOVE CORD FROM USB PORT, CORD BROKE IN HALF. NO REPORT OF USER OR PATIENT HARM.

Additional Manufacturer Narrative

INITIAL REPORT OF (B)(4) REV L - 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. SEVERITY -11. NEW POEWR SUPPLY NVARM2 SENT OT CUSTOMER, REQUESTED DEVICE RETURNED.