KINOVA
Received Jul 26, 2024 · Event occurred May 29, 2024
Report 3009538853-2024-00001 · MDR key 19838253
Device
Product problems
- Fire
- Fire
Patient
NA · Female
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
KINOVA'S INVESTIGATION OF THE EVENT, INCLUDING A PHYSICAL INSPECTION OF THE JACO ARM AS INSTALLED ON THE USER'S WHEELCHAIR, DETERMINED THAT, IN ONE SPECIFIC POSITION, THE WHEELCHAIR WAS LIVE WITH 24 VOLTS DC CURRENT. THE WHEELCHAIR SPECIALIST INVESTIGATING THE EVENT CONFIRMED THAT THE CURRENT CAME FROM A WHEELCHAIR POWER MODULE THAT WAS DAMAGED, ALLOWING CONTACT BETWEEN POWER PINS AND THE WHEELCHAIR FRAME. THE JACO ARM WAS DAMAGED BY THE CONTACT IT MADE WITH THE ARMREST OF THE WHEELCHAIR. THE CURRENT FROM THE WHEELCHAIR FLOWING THROUGH THE DAMAGED PART OF THE JACO IS THE CAUSE OF THE FIRE. UPON FURTHER INVESTIGATION, KINOVA DETERMINED THAT THE COMBINATION OF A WHEELCHAIR EXHIBITING ELECTRICAL LEAKAGE WITH A DAMAGED JACO ARM (ESPECIALLY DAMAGED COATING OR MISSING PLASTIC RING PART ) COULD RESULT IN A FIRE IF THE JACO ARM IS IN CONTACT WITH THE FAULTY WHEELCHAIR. THE ELECTRICAL CURRENT MAY FLOW THROUGH THE ROBOTIC ARM, RESULTING IN SMOKE, MELTING OF THE ARM, AND/OR FIRE.
Description of Event or Problem
A USER REPORTED THAT: "... SMOKE STARTED POURING OUT OF THE [JACO] ARM AND THE CASING MELTED". THE JACO ARM WAS NOT IN USE AT THE TIME OF THE EVENT AND WAS STOWED UNDER THE WHEELCHAIR'S ARMREST. THE USER'S CAREGIVER DISCONNECTED THE ARM AND THERE WAS NO INJURY TO THE USER OR CAREGIVER.