IBOT PMD
Received Mar 31, 2025 · Event occurred Mar 14, 2025
Report 3014522447-2025-00002 · MDR key 21734769
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
58 YR · Male
- Laceration(s)
- Laceration(s)
Narrative
Additional Manufacturer Narrative
MOBIUS MOBILITY INTERVIEWED THE USER AND RETRIEVED THE EVENT/ALARM DATA AND BLACK-BOX DATA FROM THE DEVICE. THE DATA CONFIRMS THAT ON 3/12/25, AT 13:11:00, THE DEVICE ROLL LIMIT WAS EXCEEDED WHILE IN 4-WHEEL MODE, INDICATING FAILURE OF THE OPERATOR TO PROPERLY CONTROL THE DEVICE. BLACK BOX DATA SHOWS THE DEVICE MOVING FORWARD ON LEVEL GROUND IN 4-WHEEL MODE, THEN DECELERATING. THE CLUSTER ANGLE DIPS JUST PRIOR TO THE ROLL ANGLE INDICATING THE TIP. THE DATA IS CONSISTENT WITH THE USER DESCRIPTION OF NOT GOING OFF THE CURB STRAIGHT CAUSING THE DEVICE TO TIP OVER SIDEWAYS. NO DEVICE MALFUNCTION WAS INDICATED IN THE LOGS. ASSESSMENT OF THE LOGS CORROBORATED THE USER'S ACCOUNT THAT A FALL HAD OCCURRED AND INDICATED THAT THE FALL WAS DUE TO USER ERROR.
Description of Event or Problem
USER'S WIFE CALLED INDICATING HER HUSBAND HAD TIPPED OVER SIDEWAYS IN HIS IBOT WHILE AWAY ON VACATION. SHE SAID HE WAS GOING OFF A CURB WITH A GLASS IN HIS HAND AND TIPPED THE DEVICE OVER, BREAKING THE GLASS, WHICH RESULTED IN A SMALL CUT. THE CUT FROM THE GLASS RESULTED IN 4 STICHES.