NVCAM

Description of Event or Problem

PART NVCAM - NATUS NICVIEW 2.0 CAMERA, THE WIRE TO THE CAMERA MELTED. NO HARM TO PATIENT OR USER.

Additional Manufacturer Narrative

INITIAL REPORT REF NATUS COMPLAINT# (B)(4) (RELATED TO REPORT, (MW5145982) THAT WAS RECEIVED THROUGH FDA'S MEDSUN). THE COMPLETED QUESTIONNAIRE WAS RETURNED FROM THE CUSTOMER. IT NOTED THAT NO MEDICAL INTERVENTION WAS REQUIRED AND THEY WERE UNSURE IF THE DEVICE WAS OVER THE PATIENT WHEN THE INCIDENT OCCURRED. PHOTOS OF THE AFFECTED DEVICE WERE ALSO PROVIDED BY THE CUSTOMER. SECTION D4. UDI NUMBER NOT APPLICABLE. FURTHER INVESTIGATION TO BE CARRIED OUT.

Description of Event or Problem

PART NVCAM - NATUS NICVIEW 2.0 CAMERA, THE WIRE TO THE CAMERA MELTED. NO HARM TO PATIENT OR USER.

Additional Manufacturer Narrative

FOLLOW UP REPORT 001 REF NATUS COMPLAINT# (B)(4). SECTION D4. UDI NUMBER NOT APPLICABLE. INSTALL DATE: 27-OCT-2022. DEVICE HISTORY RECORD WAS REVIEWED AND NO RELATED FAULTS/ISSUE FOUND. NO RELATED CAPAS RISK MANAGEMENT FILE REVIEW: PER (B)(4) REV I NICVIEW 2.0 RISK ANALYSIS, HAZARD ID 19.1. CAUSE - SHORT CIRCUIT DUE TO DAMAGED LOW VOLTAGE CABLE COMPONENTS, SUCH AS MICRO-USB CONNECTOR, CABLE, ETC. EFFECT (HARM) - MINOR USER BURN. THE HAZARDS IDENTIFIED HAVE RBA RATING OF LOW AND ARE DEEMED BROADLY ACCEPTABLE. THE UNIT (PN NVCAM, SN B8:27:BE:60:8E:ED) WAS RETURNED. THE UNIT HAD VISIBLE BROWN DISCOLORATION OF THE PLASTIC HOUSING MATERIAL NEAR THE USB CONNECTOR CONSISTENT WITH BEING EXPOSED TO A HEAT SOURCE. THE BROWN DISCOLORATION ON THE HOUSING WERE ON ONLY ONE SIDE, THE SIDE NEAR THE SERIAL NUMBER LABEL. THE BROWN DISCOLORATION WAS ONLY ON THE OUTSIDE OF THE HOUSING AND DID NOT EXTEND INSIDE OF THE HOUSING. THERE WAS VISIBLE DEFORMATION OF THE METAL SHELL OF THE USB CONNECTOR MOUNTED TO THE PCB INSIDE OF THE UNIT. THIS IS INDICATIVE OF A FORCE APPLIED TO THE CABLE HIGH ENOUGH TO BEND THE HOUSING. THERE WAS SOME BLACK/BROWN RESIDUE INSIDE THE USB CONNECTOR ON THE BOARD ON THE SAME SIDE AS THE BROWN DISCOLORATION OF THE HOUSING. THERE IS A STANDOFF AND SCREW ON THE SAME SIDE OF THE CONNECTOR AS THE DISCOLORATION, AND SOME MOTTLED DISCOLORATION OF THE SURFACE OF THE STANDOFF AND SCREW. THE SCREW IS ON THE OPPOSITE SIDE OF THE BOARD AS THE USB CONNECTOR AND THERE ARE NO SIGNS OF DISCOLORATION ON THE OTHER SIDE OF THE BOARD THIS FAR AWAY FROM THE CONNECTOR. IT APPEARS THAT THE DISCOLORATION OF THE STANDOFF AND SCREW IS DUE TO SOME CORROSION FROM EXPOSURE TO A LIQUID OR CHEMICAL. THE MATING USB CABLE THAT THE CUSTOMER SENT A PICTURE OF THAT SHOWED SIGNS OF MELTING WAS NOT RETURNED. ROOT CAUSE/PROBABLE ROOT CAUSE: IT APPEARS THE SOURCE OF THE HEAT WAS OUTSIDE OF THE ENCLOSURE, LIKELY A SHORT IN THE MATING USB CABLE POTENTIALLY CAUSED BY PHYSICAL DAMAGE AS EVIDENCED BY THE BENT CONDITION OF THE USB CONNECTOR. POTENTIALLY SOME EXPOSURE TO A LIQUID INSIDE THE HOUSING, THE SOURCE OF THE OXIDATION OF THE STANDOFF AND SCREW IS UNKNOWN. RECOMMENDED ACTIONS: MONITOR FOR FUTURE COMPLAINTS OF THE SAME TYPE TO DETERMINE IF THERE IS A QUALITY ISSUE WITH THE CABLES THE FAILURE WAS REVIEWED, AND IT WAS AGREED THAT THE LOW POWER IN THE USB CABLE WOULD NOT BE SUFFICIENT TO CHANGE PATIENT OR USER RISK.