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 Code	Laceration(s) (1946)
Date of Event	03/14/2025
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
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.

• 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: 21734769
• Report Number: 3014522447-2025-00002
• Device Sequence Number: 14480357
• 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
• Type of Report: Initial
• Report Date (Section B): 03/31/2025

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2025
• Initial Report FDA Received Date: 03/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2022
• 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: Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 93 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White