MAUDE Adverse Event Report: MOBIUS MOBILIYT LLC. IBOT PMD

Model Number	IBOT PMD
Health Effect - Clinical Codes	Fall (1848); Bone Fracture(s) (1870)
Date of Event	03/31/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
While showing the ibot® pmd to a friend, the user was driving on wet grass in balance mode to try to force an auto transition as a demonstration of this safety feature.Using balance mode on wet surfaces is warned against during training and in the manual: "warning never transition into, or drive in balance mode on wet, uneven, unstable or slippery surfaces.The ibot® pmd uses traction to maintain its balance, and could slip on some surfaces." when the device nevertheless maintained traction and remained in balance mode, the user went into the menu and initiated a forced power off, which resulted in the device tipping over.The fall resulted in the user breaking his toe.This is also warned against during training and in the manual: "warning operating the forced power off when in balance or stair mode can cause the device to fall over.The device will fall unless someone is capable of keeping it upright in balance mode or you or your assistant can hold onto the handrail or assist handle in stair mode." the user indicated that he knows and understands the incident was "user error" and not due to a malfunction of the device.
Event or Problem Description
User reported that he went into the menu and initiated a forced power off while in balance mode, which resulted in the device tipping over.The fall resulted in the user breaking his toe.

• Brand Name: IBOT PMD
• Common Device Name: IBOT
• Manufacturer (Section D): MOBIUS MOBILIYT LLC.; 540 north commercial st.; suite 310; manchester NH 03101
• MDR Report Key: 11703587
• Report Number: 3014522447-2021-00002
• Device Sequence Number: 11736150
• Product Code: IMK
• UDI-Device Identifier: 00857584008003
• UDI-Public: 00857584008003
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K172601
• 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): 04/01/2021

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: 04/01/2021
• Initial Report FDA Received Date: 04/21/2021
• 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: 40 YR