MAUDE Adverse Event Report: MOBIUS MOBILIYT LLC. IBOT PMD

Model Number	IBOT PMD
Health Effect - Clinical Codes	Fall (1848); Laceration(s) (1946)
Date of Event	02/20/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device involved in the incident was brought back to mobius mobility and evaluated.Engineering pulled the electronic logs from the device and found no system failures or issues with the device.The log data captured at the time of the event was evaluated.The data supports that user did not correct the pitch forward command used to transition to the next lower step in stair mode, resulting in the ibot continuing to pitch forward giving the resulting wrench code.Engineering also performed stair climbing test with the device and found it to be functioning normally.From the data and the photos of the stairs that the incident took place on it is believed that the accident was user error.The railing was inadequate for the user to grasp from underneath; the user manual and training manual instruct to grasp the handrail with one hand underneath (palm facing up) and one hand above (palm facing down).
Event or Problem Description
User reported a forward fall of the device while attempting to descend a set of stairs in stair mode.On the bottom step, he came down hard and was thrown from the device resulting in a cut on his eyebrow that required stitches.Mobius verified that the user was not wearing his hip belt at the time.

• 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: 11477294
• Report Number: 3014522447-2021-00001
• Device Sequence Number: 19686440
• 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): 03/12/2021

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: 02/20/2021
• Initial Report FDA Received Date: 03/12/2021
• 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: 25 YR