NOMAD PRO 2

Additional Manufacturer Narrative

VISUAL EVALUATION FROM FIELD PHOTOS WAS CONDUCTED. BASED ON THE VISUAL EVALUATION, IT APPEARS THAT A THERMAL EVENT TOOK PLACE WITHIN THE HANDSET/BATTERY OF THE DEVICE, RESULTING IN A CHARRING APPEARANCE OF THE AFFECTED HANDSET/BATTERY. VISUAL EVALUATION ALSO SHOWS A CRACK IN THE HANDSET THAT STARTS AT THE CONNECTION POINT TO THE X-RAY UNIT AND FOLLOWS DOWN TO THE X-RAY TRIGGER, AS WELL AS SHOWS A MISSING BATTERY PRINTED CIRCUIT BOARD COVER. IT HAS BEEN CONCLUDED THAT A COMPONENT ON THE PRINTED CIRCUIT BOARD OF THE HANDSET/BATTERY FAILED. HOWEVER, THE ROOT CAUSE OF THE FAILURE IS UNKNOWN.

Description of Event or Problem

PER (B)(4): HANDSET CAUGHT ON FIRE - NO INJURY OR DEATH. IMPACT TO PATIENT CARE PROCESS. PATIENTS MUST BE MOVED TO DIFFERENT ROOMS. NO OTHER DAMAGE REPORTED.

Additional Manufacturer Narrative

THE DEVICE WAS RETURNED AND AN INVESTIGATION WAS COMPLETED. UPON RECEIPT OF THE DEVICE, IT WAS NOTED THAT THE HANDSET HAD SUFFERED SUBSTANTIAL DAMAGE BOTH MECHANICAL AND FROM HEAT. THE HANDSET CASE SHOWED SIGNS OF CHARRING FROM HEAT BUT THE CASE HANDSET INSERT (COVER) DID NOT. THIS INDICATES IT WAS NOT INSTALLED WHEN THE INCIDENT OCCURRED. THERE WAS ALSO MECHANICAL DAMAGE TO THE HANDSET RIGHT SIDE AND THE UPPER SCREW FLANGES. THIS INDICATES THE HANDSET HAD BEEN EXPOSED TO EXTERNAL FORCE (DROPPED). THE BATTERY MANAGEMENT SYSTEM PRINTED CIRCUIT BOARD HAD HEAT DAMAGE AND CHARRING CENTERED AROUND THE P2 (POSITIVE BATTERY LEAD SOLDER CONNECTION POINT), AND THE BATTERY LEAD HAD BECOME DESOLDERED BY THE HEAT. THERE WAS ALSO HEAT DAMAGE CENTERED AROUND THE P1 (NEGATIVE BATTERY LEAD SOLDER CONNECTION POINT). DAMAGE AT THESE LOCATIONS INDICATES HIGH CURRENT FLOWING THROUGH THE BATTERY LEADS. NORMALLY, THE BATTERY MANAGEMENT SYSTEM MONITORS AND LIMITS THE FLOW OF ENERGY. THE EVIDENCE INDICATES THAT A SHORT OCCURRED WHICH BYPASSED PROTECTION. THE HANDSET RELEASE SPRINGS ARE ON EITHER SIDE OF THE CIRCUIT BOARD OUTSIDE OF THE HANDSET INSERT. WHEN THE INSERT IS MISSING, IT IS POSSIBLE THAT A SPRING DISLODGE AND SHORT CIRCUIT BETWEEN THE BATTERY POSITIVE AND NEGATIVE ON THE PRINTED CIRCUIT BOARD. THIS DIRECTLY SHORT CIRCUITS THE BATTERY CAUSING HEAT DAMAGE AND CHARRING AS SEEN IN THIS CASE. THE HANDSET RELEASE SPRINGS WERE MISSING FROM THE DELIVERY AND COULD NOT BE EVALUATED. THE SUSPECTED ROOT CAUSE IS THAT THE HANDSET HAS BEEN SUBJECTED TO EXTERNAL FORCE (DROPPED) AND MECHANICAL DAMAGE RESULTED IN THE HANDSET INSERT FALLING OUT. THIS SITUATION MADE A SHORT CIRCUIT POSSIBLE WHICH CAUSED THE HEAT DAMAGE. THIS CONCLUDES THE INVESTIGATION.