Description of Event or Problem · 0
NAVIO MIDI AND NAVIO MAXI ARE SPEECH-GENERATING AAC MEDICAL DEVICES POWERED BY AN INTERNAL LITHIUM-ION POUCH BATTERY. DURING REPAIR INTAKE ON A DEVICE RETURNED ON FEBRUARY 10TH FOR UNRELATED FUNCTIONAL ISSUES, FRACTURE OF INTERNAL BATTERY MOUNTING TABS WAS IDENTIFIED WITH EVIDENCE OF PRIOR DROP OR IMPACT DAMAGE. THE FRACTURED INTERNAL HOUSING CONTACTED AND COMPROMISED THE PRISMATIC LITHIUM-ION BATTERY CASING, LEADING TO AN INTERNAL SHORT CIRCUIT AND LOCALIZED THERMAL EVENT WITH INTERNAL HEATING AND BATTERY GAS VENTING; NO THERMAL EFFECTS EXTENDED BEYOND INTERNAL COMPONENTS. THE EXTERNAL ENCLOSURE REMAINED INTACT, AND NO SUSTAINED FIRE OR EXPLOSION OCCURRED. PREVIOUSLY FIVE CASES INVOLVED FRACTURED MOUNTING TABS ONLY, WITHOUT BATTERY POUCH DAMAGE, INTERNAL SHORT, THERMAL EFFECTS, HEAT, SMOKE, OR USER EXPOSURE. THOSE CASES WERE INITIALLY ASSESSED AS NON-REPORTABLE QUALITY FINDINGS BECAUSE NO BATTERY COMPROMISE, NO HAZARDOUS SITUATION, AND NO INJURY OR POTENTIAL FOR INJURY WERE IDENTIFIED AT THE TIME. THE SIXTH CASE INVOLVING LOCALIZED THERMAL RUNAWAY TRIGGERED ESCALATION AND REPORTABILITY ASSESSMENT. NO HEALTH EFFECTS WERE OBSERVED IN ANY CASE. NO INJURIES, CLINICAL SIGNS, OR SYMPTOMS OCCURRED, AND NO MEDICAL INTERVENTION WAS REQUIRED. THE OVERALL HEALTH IMPACT IS CLASSIFIED AS NO SERIOUS OUTCOME, WITH THE ONLY OBSERVED EFFECT BEING TEMPORARY DEVICE MALFUNCTION REQUIRING REPAIR.