IBOT PMD
Received Dec 15, 2025 · Event occurred Nov 11, 2025
Report 3014522447-2025-00010 · MDR key 23809983
Device
Generic name
Ibot
Manufacturer
Mobius Mobility Llc.Model number
IBOT PMDCatalog number
MMPX-10000-000
Lot number
N/A
Product problems
- Use of Device Problem
- Use of Device Problem
Patient
50 YR · Male
- Bone Fracture(s)
- Concussion
- Bone Fracture(s)
- Concussion
Narrative
Additional Manufacturer Narrative
THE ASSISTANT WAS DESCENDING THE STAIRS WITH THE USER IN THE WHEELCHAIR AT THE TIME OF THE EVENT. THEY HAD NOT USED THE STAIR CLIMBING FEATURE IN 6 MONTHS. FROM THE DESCRIPTION OF THE EVENT AND EMAILS WITH THE AUTHORIZED REPRESENTATIVE, IT APPEARS THAT THE USER'S ASSISTANT MAY HAVE LOST CONTROL OF THE DEVICE AT OR NEAR THE BOTTOM OF THE STAIRS, RESULTING IN A FALL FORWARD AT THE BASE OF THE STAIRS. MOBIUS MOBILITY RETRIEVED LOGS AND EVENT DATA FROM THE USER'S DEVICE FOR REVIEW OF THE INCIDENT. NO DEVICE MALFUNCTION IS INDICATED IN THIS DATA. A CLUSTER SAFETY LOCK WAS RECORDED. A CLUSTER SAFETY LOCK IS WHEN THE DEVICE STOPS CLUSTER ROTATION UPON DETECTION OF LOSS OF PITCH CONTROL BY THE USER OR ASSISTANT DURING STAIR CLIMBING OR DESCENDING. A CLUSTER SAFETY LOCK IS INTENDED TO STOP MOVEMENT IN A POTENTIALLY UNSAFE SITUATION AND AID THE USER OR ASSISTANT IN CORRECTING THE PITCH. IF THE PITCH IS NOT CORRECTED IN A TIMELY MANNER THE DEVICE CAN FALL FORWARD. THE DEVICE OPERATED AS DESIGNED AND ASSISTANT ERROR IS SUSPECTED, AS WE RECOMMEND USING THE STAIR CLIMBING FEATURE REGULARLY TO KEEP A LEVEL OF FAMILIARITY IN CONTROLLING THE DEVICE ON THE STAIRS.
Description of Event or Problem
ACCIDENT OCCURS INDOORS GOING DOWNSTAIRS. USER HAD AN ASSISTANT DURING THIS EVENT. ON THE LAST STEP OF THE STAIRS THE CHAIR GOES UP ON TWO WHEELS AND INSTEAD OF CLIMBING DOWN IT FELL FACE FRONT ON A DOOR INFRONT OF THE STAIRS. THE USER'S RESULTING IN AN ANKLE FRACTURE ON THE LEFT AND A TARSAL FRACTURE AND A HEAD INJURY. THE USER WAS FASTENED IN A BELT. THEY HAD GONE UP THE STAIRS PRIOR WITHOUT ANY DIFFICULTIES. THEY HAD NOT USED THE STAIR CLIMBER IN 6 MONTHS BEFORE THIS HAPPENED.
Remedial action
- Inspection