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); Multiple Fractures (4519)
Date of Event	08/02/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On (b)(6) 2025, mobius mobility was notified by the user's caregiver regarding a stair-related incident resulting in injury.The device was not returned; however, there was access to retrieve event logs and black box data remotely on (b)(6) 2025.Additionally, on (b)(6) 2025 mobius mobility was able to evaluate and test the device at the users home and confirmed that there was no malfunction of the device.The investigation was conducted by on site testing of the ibot involved in the reported incident, and reviewing service notes, device data and review of the production & patient records.Due to data wrapping and limitation of event log memory capacity, only alarm log data is available for the date involving the reported incident at the time of accessing the data on the device.At 13:06:34 gmt on (b)(6) 2025 the device reported a controller failure condition due to pitch limit exceeded.No other alarm data is present in the logs relevant to the reported incident.Based on the evaluation/testing of the device and the limited data available, no device malfunction is indicated in the reported incident.
Event or Problem Description
An ibot user called on (b)(6) 2025, to report they had an incident in stair mode resulting in an injury.The ibot occupant broke his fibula & tibia, after the device tipped over on the stairs during an assisted stair climb.The assistant also fell during the event resulting in no injuries that required medical intervention.

• 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: 22923766
• Report Number: 3014522447-2025-00008
• Device Sequence Number: 9156627
• 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: Consumer
• Initial Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 08/29/2025

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: Lay User/Patient
• Device Model Number: IBOT PMD
• Device Catalogue Number: MMPX-10000-000
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2025
• Initial Report FDA Received Date: 08/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/08/2024
• 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: 67 YR
• Patient Sex: Male
• Patient Weight: 86 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White