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); Multiple Fractures (4519); Vertebral Fracture (4520)
Date of Event	06/30/2025
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
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.

• 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: 22612779
• Report Number: 3014522447-2025-00007
• Device Sequence Number: 5385014
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 07/25/2025

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: 06/30/2025
• Initial Report FDA Received Date: 07/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/09/2025
• 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: 25 YR
• Patient Sex: Male
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White