NICVIEW 2.0 CAMERA

Additional Manufacturer Narrative

FINAL REPORT REF NATUS COMPLAINT#(B)(4). NO RELATED CAPAS. (B)(4) REV J NICVIEW RISK ANALYSIS SPREADSHEET (RAS) HAZARD ID 19.1 - SHORT CIRCUIT DUE TO DAMAGED LOW VOLTAGE CABLE COMPONENTS, SUCH AS MICRO-USB CONNECTOR, CABLE, ETC. EFFECTS (HARM) - MINOR USER BURN RISK - LOW THE HAZARDS IDENTIFIED HAVE RBA RATING OF LOW AND ARE DEEMED BROADLY ACCEPTABLE. THESE RISKS HAVE BEEN REVIEWED TO DETERMINE IF ANY FURTHER CONTROL MEASURES MAY BE IMPLEMENTED SO AS TO FURTHER REDUCE THE RISK AS FAR AS POSSIBLE. RISK OUTWEIGHED BY BENEFIT OF USE OF DEVICE. A REPLACEMENT NICVIEW 2.0 US POWER SUPPLY KIT NVPWS-001 WAS SENT TO THE CUSTOMER, AND THEY WERE REQUESTED TO RETURN THE DEFECTIVE DEVICE. DEFECTIVE DEVICE RECEIVED, CONFIRMED CUSTOMER COMPLAINT OF BROKEN LOW VOLTAGE CABLE DUE TO FATIGUE AT JOINT.

Description of Event or Problem

NO PATIENT OR USER HARM CAUSED BY THIS EVENT NURSING STAFF NOTICED THAT THE CORD CONNECTING THE BATTERY TO THE ARM OF THE NATUS CAMERA WAS SPARKING. DEVICE WAS REMOVED FROM THE AREA BY IT FIELD SERVICE STAFF UNTIL A REPLACEMENT PART COULD BE FOUND.

Description of Event or Problem

NO PATIENT OR USER HARM CAUSED BY THIS EVENT. NURSING STAFF NOTICED THAT THE CORD CONNECTING THE BATTERY TO THE ARM OF THE NATUS CAMERA WAS SPARKING. DEVICE WAS REMOVED FROM THE AREA BY IT FIELD SERVICE STAFF UNTIL A REPLACEMENT PART COULD BE FOUND.

Additional Manufacturer Narrative

INITIAL REPORT REF NATUS COMPLAINT# (B)(4). NO RELATED CAPAS. (B)(4) REV J NICVIEW RISK ANALYSIS SPREADSHEET (RAS). HAZARD ID 19.1 - SHORT CIRCUIT DUE TO DAMAGED LOW VOLTAGE CABLE COMPONENTS, SUCH AS MICRO-USB CONNECTOR, CABLE, ETC. EFFECTS (HARM) - MINOR USER BURN RISK - LOW. THE HAZARDS IDENTIFIED HAVE RBA RATING OF LOW AND ARE DEEMED BROADLY ACCEPTABLE. THESE RISKS HAVE BEEN REVIEWED TO DETERMINE IF ANY FURTHER CONTROL MEASURES MAY BE IMPLEMENTED SO AS TO FURTHER REDUCE THE RISK AS FAR AS POSSIBLE. RISK OUTWEIGHED BY BENEFIT OF USE OF DEVICE. A REPLACEMENT NICVIEW 2.0 US POWER SUPPLY KIT NVPWS-001 WAS SENT TO THE CUSTOMER, AND THEY WERE REQUESTED TO RETURN THE DEFECTIVE DEVICE.