THE DEVICE WAS RETURNED FOR REPAIR ON (B)(4) 2019, WITH AN EVALUATION BEING PERFORMED ON (B)(4) 2019, BASED ON THE INITIAL COMPLAINT OF SYSTEM FAILURE. THIS INITIAL EVALUATION IDENTIFIED A POTENTIAL THERMAL EVENT. UPON FURTHER VISUAL INSPECTION, IT APPEARS THAT A THERMAL EVENT OCCURRED. IT IS NOT POSSIBLE TO DETERMINE THE EXACT SEQUENCE OF EVENTS THAT LED TO THE THERMAL EVENT. HOWEVER, THERE IS EVIDENCE THAT A SHORT OCCURRED IN THE UPPER BATTERY PACK BETWEEN THE CELLS AND PRINTED CIRCUIT BOARD. THERE WAS A BLACKENING ON THE TOP OF THE LOWER BATTERY PACK AND ITS PRINTED CIRCUIT BOARD. CELLS 2 AND 3 APPEAR TO HAVE BEEN INVOLVED IN THE THERMAL EVENT, LIKELY BY SUPPLYING ENERGY INTO A FAULT IN THE BOARD. ADDITIONALLY, THERE WAS A SLIGHT MELTING OF THE HANDSET PLASTIC ENCLOSURE. THIS CONCLUDES THE INVESTIGATION.
D
Patient 1
IT WAS INITIALLY REPORTED ON (B)(6) 2019 THAT THE DEVICE WAS GIVING A SYSTEM FAILURE MESSAGE. THERE WAS NO REPORT OF INJURIES, PATIENT OR USER INVOLVEMENT, AND NO IMPACT TO PATIENT CARE. THE DEVICE WAS RETURNED FOR REPAIR AND WAS RECEIVED BY THE MANUFACTURER ON (B)(4) 2019. DURING AN ASSESSMENT BY THE REPAIR DEPARTMENT ON (B)(4) 2019, A POSSIBLE THERMAL EVENT WAS IDENTIFIED ON ONE OF THE HANDSETS RETURNED WITH THE DEVICE.