NICVIEW 2.0 CAMERA

Description of Event or Problem

NICVIEW 2.0 CAMERA - THE CUSTOMER REPORTED "ELECTRICAL SPARKING" FROM THE CAMERA AND THE "NURSE'S FINGER WAS ELECTRICALLY BURNED." THE CUSTOMER REPORTED A DAMAGE TO THE ARM AND THE USB, AND PROVIDED PHOTOS.

Additional Manufacturer Narrative

FOLLOW UP REPORT REF NATUS COMPLAINT#(B)(4). RISK REVIEW WAS REVISED AS BELOW: PER (B)(4) REV J NICVIEW RISK ANALYSIS SPREADSHEET (RAS). HAZARD ID 4.6 -DAMAGE TO INTERCONNECT WIRES/CABLES. EFFECTS (HARM) - ELECTRICAL SHOCK TO USER - TISSUE DAMAGE/BURNS OR TISSUE DEATH (NECROSIS) THE HAZARD IDENTIFIED HAS RBA RATING OF LOW AND IS DEEMED BROADLY ACCEPTABLE. INSTALL DATE OF AFFECTED DEVICE WAS (B)(6) 2024. THE DEFECTIVE CAMERA WAS RETURNED TO NATUS FOR EVALUATION, BUT NOT THE ARM. THE ENGINEERING TEAM EVALUATED THE CAMERA AND DIDN'T FIND ANYTHING THAT WOULD HAVE CAUSED SPARKING. THEY STATED THAT THE SPARKING MOST LIKELY CAME FROM A BENT OR DAMAGED MICRO-USB CONNECTOR ON THE ARM. IT WAS CONFIRMED THAT THE CAMERA FUNCTIONED AND ALL BUTTONS WORKED. THEY ALSO STATED THAT IF THE CONNECTOR ON THE ARM WAS DAMAGED, THE WIRES COULD BE EXPOSED AND CAUSE A SPARK. THE DEVICE HISTORY RECORD WAS REVIEWED WITH NO ISSUES NOTED. IT HAS BEEN MORE THAN 45 DAYS SINCE IT WAS REQUESTED FOR THE RETURN OF THE ARM. MULTIPLE REQUESTS WERE MADE BY TECHNICAL SERVICE. THE PART HAS NOT BEEN RECEIVED BACK. IF RETURNED AT A LATER DATE, SERVICE REPAIR INVESTIGATIONS WILL BE CONDUCTED DURING THE REPAIR PROCESS. COMPLAINT WILL ALSO BE INCLUDED IN TRENDING DATA FOR FURTHER REVIEW.

Additional Manufacturer Narrative

INITIAL REPORT REF NATUS COMPLAINT#(B)(4). UDI# NOT APPLICABLE. NO RELATED CAPAS. PER (B)(4) 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. A REPLACEMENT CAMERA (SN (B)(6)) AND ARM WAS SENT TO THE CUSTOMER, AND THEY WERE REQUESTED TO RETURN THE DEFECTIVE CAMERA AND ARM FOR INVESTIGATION.

Description of Event or Problem

NICVIEW 2.0 CAMERA - THE CUSTOMER REPORTED "ELECTRICAL SPARKING" FROM THE CAMERA AND THE "NURSE'S FINGER WAS ELECTRICALLY BURNED." THE CUSTOMER REPORTED A DAMAGE TO THE ARM AND THE USB, AND PROVIDED PHOTOS.