MAUDE Adverse Event Report: MOBIUS MOBILITY LLC. IBOT PMD

Model Number	IBOT PMD
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Concussion (2192)
Date of Event	11/11/2025
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
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.

• Brand Name: IBOT PMD
• Common Device Name: IBOT
• Manufacturer (Section D): MOBIUS MOBILITY LLC.; 540 north commercial st.; suite 310; manchester 03101
• Manufacturer (Section G): MOBIUS MOBILITY LLC.; 540 n. commercial street; suite 310; manchester NH 03101
• Manufacturer Contact: joseph sullivan ; 540 n. commercial street; suite 310; manchester, NH 03101 ; 8333464268
• MDR Report Key: 23809983
• Report Number: 3014522447-2025-00010
• Device Sequence Number: 7621986
• Product Code: IMK
• UDI-Device Identifier: 00857584008010
• UDI-Public: 00857584008010
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K210920
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 12/15/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: IBOT PMD
• Device Catalogue Number: MMPX-10000-000
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2025
• Initial Report FDA Received Date: 12/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/21/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 50 YR
• Patient Sex: Male
• Patient Weight: 100 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White