NICVIEW 2.0 CAMERA

Description of Event or Problem

NICVIEW 2.0 CAMERA FELL ON BABY. THE CUSTOMER REPORTED NO SERIOUS INJURY OR DEATH.

Additional Manufacturer Narrative

FOLLOW UP REPORT 002 REF NATUS COMPLAINT# (B)(4). THE CUSTOMER REPORTED THAT THE NICVIEW ARMS SLIPPED FROM THE MOUNT BUT DIDN'T BREAK AND WERE ABLE TO BE REATTACHED. DUE TO THE LENGTH OF TIME SINCE THE EVENT WAS REPORTED, THE CUSTOMER IS UNABLE TO LOCATE THE SPECIFIC ARMS THIS OCCURRED WITH AS THERE WAS NO RECORD OF THE SPECIFIC EQUIPMENT NUMBER, THEREFORE UNABLE TO RETURN THE DEFECTIVE PART. THIS FAILURE WAS NOT CONFIRMED. THE COMPLAINT COULD NOT BE VERIFIED, MONITOR FOR FUTURE OCCURRENCE. LOW SAFETY RISK OF HARM, INDIVIDUAL COMPLAINT RELATED TO ISSUE STATED. NO DEATH OR SERIOUS INJURY, CONSIDERED A CUSTOMER INCONVENIENCE. COMPLAINT WILL BE INCLUDED IN TRENDING DATA FOR FURTHER REVIEW AND INVESTIGATION IF NEEDED.

Additional Manufacturer Narrative

FOLLOW UP REPORT 001 REF NATUS COMPLAINT# (B)(4). THE SERVICE TECHNICIAN EMAILED ADDITIONAL QUESTIONS ABOUT THE EQUIPMENT INVOLVED IN THE INCIDENT. THE NURSE REPORTED THAT 2 SEPARATE CAMERAS FELL WITHOUT BEING JOSTLED. THEY FURTHER STATED THAT IT WAS DIFFICULT TO DETERMINE IF IT IS THE MOUNTING EQUIPMENT AT THE BASE OF THE CAMERA OR THE WALL MOUNT. THEY ALSO INDICATED THAT THE "ARMS DO HAVE A TENDENCY TO DROP AS WELL, ALMOST AS THOUGH THEY ARE TOO HEAVY SOMETIMES PUTTING PRESSURE ON THE MOUNTING EQUIPMENT ON THE ARM, BUT THIS IS NOT CONSISTENT FROM CAMERA TO CAMERA." FURTHER INVESTIGATION TO BE CARRIED OUT. AWAITING RETURN OF THE AFFECTED PRODUCT. SECTION D4., NO UDI NUMBER DOCUMENTED AS THIS IS A NON-MEDICAL DEVICE.

Description of Event or Problem

NICVIEW 2.0 CAMERA FELL ON BABY. THE CUSTOMER REPORTED NO SERIOUS INJURY OR DEATH.

Additional Manufacturer Narrative

INITIAL REPORT REF NATUS COMPLAINT# (B)(4). NICVIEW 2.0 CAMERA FELL ON BABY. NO INJURIES REPORTED. NO ENVIRONMENTAL OR SAFETY CONCERNS. FURTHER INVESTIGATION TO BE CARRIED OUT. THE SERVICE TECHNICIAN SENT AN INQUIRY TO THE CUSTOMER TO CONFIRM IF THE DEFECTIVE PART WAS THE CAMERA OR THE ARM ( REF PART NVARM). PER (B)(4) REV G NICVIEW 2.0 RISK ANALYSIS SPREADSHEET (RAS). HAZARD ID 6.1 - UNIT IS NOT PROPERLY ASSEMBLED - USER MOUNTS THE CAMERA INSIDE THE INCUBATOR AND CAMERA FALLS ON THE PATIENT. EFFECTS (HARM) - PATIENT INJURY. RESIDUAL RISK = LOW AND ACCEPTABLE. 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.

Description of Event or Problem

NICVIEW 2.0 CAMERA FELL ON BABY. THE CUSTOMER REPORTED NO SERIOUS INJURY OR DEATH.