KAVO NOMAD PRO 2

Additional Manufacturer Narrative

VISUAL EVALUATION FROM PHOTOS PROVIDED BY INITIAL REPORTER WAS CONDUCTED. BASED ON THE VISUAL EVALUATION OF PHOTOS, IT APPEARS A FAILURE OCCURRED BETWEEN THE BATTERY HANDSET AND THE TUBEHEAD, BASED ON THE APPEARANCE OF SOOT. THE CAUSE OF THE FAILURE HAS NOT YET BEEN DETERMINED. THE UNIT IS PENDING RETURN FOR FURTHER INVESTIGATION TO CONFIRM THE FAILURE AND DETERMINE ROOT CAUSE. AN INVESTIGATION WILL BE CONDUCTED UPON RECEIPT OF THE DEVICE AND FOLLOW-UP REPORT WILL BE PROVIDED AFTER THE INVESTIGATION IS COMPLETED.

Description of Event or Problem

PER CAS-6968813-D9V4H5: IT WAS REPORTED THE DEVICE IS NOT WORKING AND SMELLS OF SMOKE. THERE WAS NO REPORT OF INJURY OR DEATH, NO IMPACT TO PATIENT CARE AND NO OTHER DAMAGE.

Additional Manufacturer Narrative

THE DEVICE WAS RETURNED AND AN INVESTIGATION WAS COMPLETED. BOTH DEVICE AND HANDSET WERE DISASSEMBLED AND EVALUATED. DEVICE SUFFERED NO DAMAGE INTERNALLY. ELECTRICAL/ELECTRONIC COMPONENTS WERE CHECKED AND FUNCTION NORMALLY. THE SPRING TERMINAL ON THE BATTERY INTERFACE BOARD HAD GOTTEN HOT ENOUGH TO IGNITE THE CIRCUIT BOARD MATERIAL, MELT THE TERMINAL SOLDER, AND DEFORM THE ENCLOSURE PLASTIC. OTHER THAN THE DAMAGED (+) TERMINAL, THE BOARD FUNCTIONS NORMALLY. THE BATTERY CORE PACK SHOWS NO SIGN OF DAMAGE, FUNCTIONS NORMALLY, AND EXTRACTED DIAGNOSTIC DATA IS NORMAL. IT WAS FOUND THAT THE SPRING TERMINALS CORRODED BY CLEANING PRODUCTS WHICH INTRODUCED HIGH RESISTANCE IN THE POWER PATH. THE INRUSH OF CURRENT WHEN EACH EXPOSURE WAS TAKEN HEATED THE SPRING. THE SPRING DETERIORATED UNTIL THE RESISTANCE CAUSED ENOUGH HEAT TO DAMAGE THE CIRCUIT BOARD. THE SAFETY MATERIALS IN THE DESIGN PREVENTED MORE EXTENSIVE DAMAGE. THE 94V-0 CIRCUIT BOARD MATERIAL DID NOT SUSTAIN A FLAME AND THE FIRE-RESISTANT PLASTIC DID NOT BURN. THE DEVICE OPERATOR MANUAL STATES "DO NOT SPRAY DISINFECTANT OR CLEANERS DIRECTLY ON THE KAVO NOMAD PRO 2, HANDSETS, CHARGING CRADLE, OR AC POWER SUPPLY. THE CONNECTING AREAS ARE OPEN TO INGRESS AND DAMAGE TO YOUR DEVICE MAY RESULT." THIS CONCLUDES THE INVESTIGATION.