MAUDE Adverse Event Report: MOBIUS MOBILITY LLC. IBOT PMD

Model Number	IBOT PMD
Medical Device Problem Code	Unintended Application Program Shut Down (4032)
Health Effect - Clinical Code	Fall (1848)
Date of Event	04/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
User stated she was in standard mode leaning her elbow on the armrest.The device was stationary on level ground.The user heard a click as of the brakes releasing, and the ibot moved as if to transition modes (into 4-wheel or balance mode) and then fell over backwards.User reported that she did not intentionally command a mode transition.User was not wearing the positioning belt.She landed on her back, with her head on the headrest, and slid out of the seat.She did not sustain any injuries.
Additional Manufacturer Narrative
The user states that she did not intentionally command mode transition, but nevertheless, the data shows the commands were received.The user controller was returned for evaluation, and no issues were identified with the user controller.Whereas the user stated she was leaning her elbow on the armrest, it is possible she accidentally pressed the mode transition shortcut and seat adjustment shortcut.As to why the device fell, investigation found a software issue in the recently-released software version running on this device.If a seat adjustment is commanded during a 24 millisecond window of a self-test which occurs approximately 1 second after transition to balance mode or after a seat adjustment in balance mode, two self-tests will interfere with each other, leading to a tip-over.

• Brand Name: IBOT PMD
• Common Device Name: IBOT
• Manufacturer (Section D): MOBIUS MOBILITY LLC.; 540 north commercial st.; suite 310; manchester NH 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: 21985757
• Report Number: 3014522447-2025-00003
• Device Sequence Number: 8479721
• 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: K243442
• 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: Repair
• Type of Report: Initial
• Report Date (Section B): 05/08/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2025
• Initial Report FDA Received Date: 05/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/19/2025
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 014522447/05052025/C/000
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White