NICVIEW 2.0 CAMERA

Additional Manufacturer Narrative

INITIAL REPORT REF NATUS COMPLAINT#(B)(4). UDI# NOT APPLICABLE EXCHANGE REPLACEMENT NICVIEW 2.0 CAMERA SN (B)(6) AND REPLACEMENT NICVIEW 2.0 MICRO USB SUPPORT BRACKET FOR CAMERA WAS SHIPPED TO THE CUSTOMER TO ADDRESS THE IMMEDIATE ISSUE. ON REVIEW OF COMPLAINT DETAILS IT WAS NOTED, THAT IT'S POSSIBLE BY COVERING THE DEVICE THE AMBIENT OPERATING TEMPERATURE WOULD BE EXCEEDED, AND INFORMED THAT ELECTRONIC DEVICES NEED PROPER VENTILATION, SO THE USE ERROR OF COVERING THIS DEVICE WAS CONSIDERED. THIS INFORMATION IS NOT IN THE RELATED IFU. QA WILL NEED TO SUBMIT AN ENGINEER CHANGE REQUEST TO GET THE IFU UPDATED. INSTALL DATE OF THE AFFECTED DEVICE: (B)(6) 2023.

Description of Event or Problem

NICVIEW 2.0 CAMERA -CAMERA OVERHEATING. CUSTOMER REPORTED THAT WHEN REPOSITIONING THE CAMERA IN THE PATIENT'S ROOM DURING CARE, THEY NOTED THE CAMERA TO BE VERY HOT TO TOUCH. NO INJURIES.

Description of Event or Problem

NICVIEW 2.0 CAMERA. CAMERA OVERHEATING. CUSTOMER REPORTED THAT WHEN REPOSITIONING THE CAMERA IN THE PATIENT'S ROOM DURING CARE, THEY NOTED THE CAMERA TO BE VERY HOT TO TOUCH. NO INJURIES.

Additional Manufacturer Narrative

FOLLOW UP REPORT 002 REF NATUS COMPLAINT#(B)(4). APRIL 18, 2024 - ECR#22700 WAS CANCELLED TO UPDATE IFU PART 028158, AS THIS WAS DONE IN ERROR. THE CURRENT IFU IS PART 043868 AND THIS IFU IS ADEQUATE. ENGINEERING'S INVESTIGATION OF THE CAMERA WITH HEAT DAMAGE NOTED THE HEAT WAS DUE TO AN EXTERNAL HEAT SOURCE (NOT CAUSED INTERNALLY), AND WAS NOT RELATED TO THE CAMERA BEING COVERED. AWAITING FINAL REVIEW OF INVESTIGATION DETAILS BEFORE CLOSURE OF COMPLAINT.

Additional Manufacturer Narrative

FOLLOW UP REPORT 003 REF NATUS COMPLAINT# (B)(4). PER DOC-023354 REV J NICVIEW 2 RISK ANALYSIS: HAZARD ID 19.1. CAUSE - SHORT CIRCUIT DUE TO DAMAGED LOW VOLTAGE CABLE COMPONENTS, SUCH AS MICRO-USB CONNECTOR, CABLE, ETC. EFFECTS (HARM)- MINOR USER BURN. RBA RATING - 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. INVESTIGATION RESULTS: THE CAMERA WAS PLUGGED IN AND ALLOWED TO REACH STEADY STATE TEMPERATURE AT A ROOM TEMPERATURE OF 24C. THE TEMPERATURE PROBE WAS USED TO MEASURE THE TEMPERATURE OF THE SURFACE OF THE CAMERA. THE HIGHEST TEMPERATURE WAS MEASURED IN THE LOWER LEFT CORNER OF THE TOUCHSCREEN WHICH WAS MEASURED AT 58.4C. IEC 60601-1 ALLOWS A MAXIMUM TEMPERATURE OF ACCESSIBLE PARTS THAT ARE LIKELY TO BE TOUCHED (GLASS) OF 80C FOR LESS THAN 1 SECOND OR 66C FOR BETWEEN 1 SECOND AND 10 SECONDS. IN NORMAL USE THE TOUCH SCREEN IS TOUCHED FOR LESS THAN ONE SECOND. THE HOT AREA OF THE CASE WAS RELATIVELY SMALL APPROXIMATELY 1CM X 1CM AND THE TEMPERATURE DROPPED OFF RAPIDLY WHEN MOVING AWAY FROM THE HOT AREA. THERE IS A VOLTAGE REGULATOR ON THE BACK OF THE SCREEN PCB THAT MAY BE THE SOURCE OF THE HEAT, WHICH IS EXPECTED. ROOT CAUSE/PROBABLE ROOT CAUSE: NO ISSUE FOUND BEYOND CUSTOMER REPORTED HOT SURFACE. THERE IS A VOLTAGE REGULATOR ON THE BACK OF THE SCREEN PCB THAT MAY BE THE SOURCE OF THE HEAT. RECOMMENDED ACTIONS: MONITOR FOR FUTURE COMPLAINTS OF THE SAME TYPE. INVESTIGATOR COMPLETION DATE: MAY 30, 2024. FAILURE CONFIRMED:NO INVESTIGATION RESULT CODE: NEURO SBU/NO ISSUES NOTED.

Description of Event or Problem

NICVIEW 2.0 CAMERA: CAMERA OVERHEATING. CUSTOMER REPORTED THAT WHEN REPOSITIONING THE CAMERA IN THE PATIENT'S ROOM DURING CARE, THEY NOTED THE CAMERA TO BE VERY HOT TO TOUCH. NO INJURIES.

Additional Manufacturer Narrative

FOLLOW UP REPORT 001 REF NATUS COMPLAINT # (B)(4). - THE UNIT WAS RECEIVED INTO NATUS FOR EVALUATION. AWAITING INVESTIGATION RESULTS. - ECR# 22700 CREATED FOR UPDATE OF THE NICVIEW IFU PART 028158 TO INCLUDE A WARNING FOR PLACING THE CAMERA NEAR THE HEATER OR COVERING THE CAMERA.

Description of Event or Problem

NIC VIEW 2.0 CAMERA -CAMERA OVERHEATING. CUSTOMER REPORTED THAT WHEN REPOSITIONING THE CAMERA IN THE PATIENT'S ROOM DURING CARE, THEY NOTED THE CAMERA TO BE VERY HOT TO TOUCH. NO INJURIES.