NICVIEW 2.0 CAMERA

Additional Manufacturer Narrative

INITIAL REPORT REF NATUS COMPLAINT # (B)(4). NO RELATED CAPAS. A REPLACEMENT NICE VIEW 2.0 WAS SENT TO THE CUSTOMER, AND THEY WERE REQUESTED TO RETURN THE DEFECTIVE DEVICE.

Description of Event or Problem

CUSTOMER REPORTS THAT CAMERA WAS USED FOR A PATIENT WHO WAS ON AN OPEN WARMER. THE CAMERA WAS NOT NEAR THE HEATING ELEMENT, NOR WAS IT DIRECTLY UNDER THE HEATING ELEMENT BUT SOMEHOW, IT "MELTED". NO ADVERSE EFFECTS TO THE USERS OR PATIENTS.

Description of Event or Problem

CUSTOMER REPORTS THAT CAMERA WAS USED FOR A PATIENT WHO WAS ON AN OPEN WARMER. THE CAMERA WAS NOT NEAR THE HEATING ELEMENT, NOR WAS IT DIRECTLY UNDER THE HEATING ELEMENT BUT SOMEHOW, IT "MELTED". NO ADVERSE EFFECTS TO THE USERS OR PATIENTS.

Additional Manufacturer Narrative

FOLLOW UP REPORT REF NATUS COMPLAINT #(B)(4). INITIAL REPORT INDICATED THE CAMERA WAS A SUFFICIENT DISCTANCE FROM A HEATING LAMP BUT ONSITE TECH CONFIRMED THAT "CAMERA GOT TOO CLOSE TO LAMP AND MELTED". THIS IS USER ERROR AND NOT A PRODUCT MALFUCTION. RISK MANAGEMENT FILE REVIEW: (B)(4): NICVIEW 2 RISK ANALYSIS RISK MANAGEMENT FILE REVISION: J CAUE: LOSS OR INTERMITTENT VIDEO STREAMING FUNCTION HARM: SYSTEM NOT AVAILABLE FOR USE CREATING INCONVENIENCE OR ANNOYANCE TO OPERATOR OR USERS. RISK HAZARD ID LINE ITEM: 14.2 RISK SEVERITY: 0 RESIDUAL RISK LEVEL: LOW. RISK LEVEL DEEMED LOW AND ACCEPTABLE.