inforMED
InjuryIMK

IBOT PMD

Received Jul 25, 2025 · Event occurred Jun 30, 2025

Report 3014522447-2025-00007 · MDR key 22612779

Device

Generic name

Ibot

Model number

IBOT PMD

Catalog number

MMPX-10000-000

Lot number

N/A

Product problems

  • Use of Device Problem
  • Use of Device Problem

Patient

25 YR · Male

  • Bone Fracture(s)
  • Concussion
  • Multiple Fractures
  • Vertebral Fracture
  • Bone Fracture(s)
  • Concussion
  • Multiple Fractures
  • Vertebral Fracture

Narrative

Additional Manufacturer Narrative

ON (B)(6) 2025, MOBIUS MOBILITY WAS NOTIFIED BY THE USER'S MOTHER REGARDING A STAIR-RELATED INCIDENT RESULTING IN INJURY. THE DEVICE WAS NOT RETURNED; HOWEVER, WHILE COORDINATING ACCESS TO RETRIEVE EVENT LOGS AND BLACK BOX DATA, THE SERVICE TEAM REMAINED IN CONTACT WITH THE FAMILY, WHO ALSO PROVIDED VIDEO FOOTAGE OF PRIOR STAIR USE ON THE SAME STAIRCASE. THE EVENT LOGS AND BLACK BOX DATA WERE RETRIEVED ON (B)(6) 2025. THE INVESTIGATION WAS CONDUCTED USING SERVICE NOTES, DEVICE DATA, AND THE VIDEO PROVIDED BY THE FAMILY. THE DATA FROM THE DEVICE SHOWS THAT WITHIN 2 MINUTES OF ENTERING STAIR MODE, AN EVENT OCCURRED IN WHICH THE DEVICE WENT INTO A CLUSTER SAFETY LOCK AND EXCEEDED IT'S ALLOWABLE PITCH LIMIT. 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. BASED ON THE DATA, A DEVICE MALFUNCTION IS NOT INDICATED, AND THE DATA IS CONSISTENT WITH LACK OF PITCH CONTROL DURING STAIR MODE OPERATION.

Description of Event or Problem

MOBIUS MOBILITY WAS NOTIFIED OF AN INCIDENT INVOLVING THE IBOT WHEELCHAIR ON (B)(6) 2025. THE ASSISTANT INDICATED THAT WHEN THE IBOT WAS IN STAIR MODE, IT DESCENDED 3 STAIRS NORMALLY AND THEN TIPPED FORWARD AND FELL DOWN PART OF THE STAIRCASE. THE PERSON IN THE SEAT FELL AND HAD A FEW BRUISES AND SCRAPES. THE ASSISTANT WENT OVER THE TOP OF THE WHEELCHAIR AND LANDED ON HER SHOULDER AND HEAD. THE ASSISTANT WAS HOSPITALIZED, RECEIVING TREATMENT FOR 3 BROKEN RIBS, A BROKEN CLAVICLE, 2 FRACTURED VERTEBRAE AND A MILD CONCUSSION.

Remedial action

  • Replace