NOMAD PRO 2
Received Oct 1, 2024 · Event occurred Sep 3, 2024
Report 3021551875-2024-00004 · MDR key 20347383
Device
Generic name
Extraoral Source X-ray System,
Manufacturer
Dental Imaging Technologies CorporationModel number
1.013.2040Product problems
- Circuit Failure
- Failure to Conduct
- Corroded
- Electrical /Electronic Property Problem
- Circuit Failure
- Failure to Conduct
- Corroded
- Electrical /Electronic Property Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE DEVICE WAS RETURNED AND AN INVESTIGATION WAS COMPLETED WITH THE ROOT CAUSE BEING IDENTIFIED AS A BATTERY DISCHARGE FROM THE POSITIVE (+) SPRING CONTACT TO THE BATTERY INTERFACE BOARD GROUND. WHEN A HANDSET IS ATTACHED TO A DEVICE OR CHARGING CRADLE, THE SPRING CONTACTS ARE DEFORMED, AND THE LOWEST COIL OF THE SPRING CAN COME IN CONTACT WITH THE SURFACE OF THE PRINTED CIRCUIT BOARD AND IMPROPER CLEANING CAN INDUCE PROBLEMS. THE SPRING CONTACTS ARE NOT TO BE CLEANED, BUT IF CLEANING AGENTS ARE ALLOWED INTO THE HANDSET, THE SPRINGS CAN CORRODE. THE ROUGH TEXTURE OF CORROSION TURNS THE BOTTOM COIL INTO A FILE WHICH CAN WEAR THROUGH THE GREEN SOLDER MASK PROTECTING THE COPPER ON THE PRINTED CIRCUIT BOARD. AT SOME POINT, CURRENT WILL BEGIN TO FLOW THROUGH THE CORRODED SPRING, WHICH MAY LEAD TO HEAT GENERATION IN AND AROUND THE SPRING CONTACT AND IN SEVERE CASES, THE HEAT CAN CAUSE THE PRINTED CIRCUIT BOARD MATERIAL TO COMBUST. ASSEMBLIES WERE DISASSEMBLED TO VERIFY NO DEGRADATION OF ELECTRICAL COMPONENTS AND TO PROVIDE CLOSER INSPECTION OF PRINTED CIRCUIT BOARD DAMAGE. EXPERIMENTS WERE CONDUCTED ON UNDAMAGED ASSEMBLIES TO CONFIRM AND REPRODUCE THE EFFECTS OF THE FAILURE MODE. THE COMBINATION OF A CORRODED SPRING TERMINAL AND A SHORT TO THE PRINTED CIRCUIT BOARD GROUND LEADS TO A LARGE, SUSTAINED CURRENT DRAW. THE CORRODED SPRING INDUCED THE DISCHARGE THROUGH THE SOLDER MASK AND CAUSED THE HEAT THAT IGNITED THE SURROUNDING BOARD MATERIAL. THE ENCLOSURE PLASTICS SUSTAINED SOME HEAT DAMAGE BUT DID NOT IGNITE AS THE CIRCUIT BOARD SELF-EXTINGUISHED, AS DESIGNED, PREVENTING A LARGER INCIDENT. THIS CONCLUDES THE INVESTIGATION.
Description of Event or Problem
IT WAS REPORTED BY CUSTOMER THAT THE NOMAD HANDSET FAILED AND WAS SMOKING AND CANNOT REMOVE BATTERY CURRENTLY ON THE UNIT. THE CUSTOMER REPORTED THERE WERE BURN AND SCORCH MARKS ON THE UNIT. CUSTOMER HAS DISCONTINUED USE OF THE UNIT. THERE WAS NO REPORT OF INJURY OR DEATH, NO IMPACT TO PATIENT CARE, AND NO OTHER DAMAGE.
Additional Manufacturer Narrative
THE UNIT HAS BEEN RETURNED AND AN EVALUATION IS ONGOING BY THE MANUFACTURER. THE CAUSE OF THE FAILURE HAS NOT YET BEEN DETERMINED. THE UNIT IS PENDING FURTHER INVESTIGATION TO CONFIRM THE FAILURE AND DETERMINE ROOT CAUSE, A FOLLOW-UP REPORT WILL BE PROVIDED AFTER THE INVESTIGATION IS COMPLETED.
Description of Event or Problem
IT WAS REPORTED BY CUSTOMER THAT THE NOMAD HANDSET FAILED AND WAS SMOKING AND CANNOT REMOVE BATTERY CURRENTLY ON THE UNIT. THE CUSTOMER REPORTED THERE WERE BURN AND SCORCH MARKS ON THE UNIT. CUSTOMER HAS DISCONTINUED USE OF THE UNIT. THERE WAS NO REPORT OF INJURY OR DEATH, NO IMPACT TO PATIENT CARE, AND NO OTHER DAMAGE.