MAUDE Adverse Event Report: MOBIUS MOBILIYT LLC. IBOT PMD

Model Number	IBOT PMD
Health Effect - Clinical Codes	Fall (1848); Unspecified Tissue Injury (4559)
Date of Event	08/11/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A trained health care professional sprained both ankles when they performed a "forced power off" in balance mode.The user was practicing all aspects of the ibot® to provide demonstrations to others.In the investigation the user indicated that he confused "forced power off" with the "power off request".Power off request has an additional step prior to shutting the down ibot®, which is what the user was expecting but was unsure of at the time of the event.He did not reference the manual.This is 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.".
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 severely spraining both ankles.

• 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: 12435190
• Report Number: 3014522447-2021-00004
• Device Sequence Number: 4738621
• 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): 09/07/2021

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: 09/07/2021
• 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: 50 YR
• Patient Weight: 79