MAUDE Adverse Event Report: MOBIUS MOBILITY LLC. IBOT PMD

Model Number	IBOT PMD
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	Vertebral Fracture (4520)
Date of Event	10/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The user reported being in balance mode when incident happened on their ramp as they drove over a loose piece of artificial turf style carpet that had moved closer to the bottom of the ramp over time.When going up the ramp the carpet slipped causing a loss of traction resulting in a rapid auto transition to maintain stability and prevent more serious issues.This resulted in the user sustaining a compression fracture of the l1 vertebra.
Additional Manufacturer Narrative
Mobius mobility received a copy of a facebook post from someone saying a customer had been injured.It appears from the post that the wheels slipped on a rug while going back into the house in balance mode and the unit rapidly auto transitioned to 4-wheel mode to ensure stability.Per the facebook post, the auto-transition event caused the customer to receive an l1 compression fracture.Per the ibot user manual, the ibot should not be used on any loose floor coverings, including loose rugs.When used on a loose surface, balance mode can detect when the ibot is beginning to slip, and this can cause a rapid auto transition to maintain stability and prevent more serious issues.Mobius mobility was able to contact the user and obtain video and retrieve the logs from the device on (b)(6) 2024.Event/alarm data confirms the device entered balance mode at 14:42:10 on 10/18/24.At 14:48:48, the device recorded a controller alert (event) indicating a balance mode loss of traction with auto-transition.No other relevant event/alarm data is present in the logs.The data is consistent with the user description and with the provided video.The device cleared a threshold in balance mode onto a piece of green carpet (turf), which was not secured to the floor.The torque provided by the device wheels moved the carpet resulting in the device's detection of loss of traction, and auto-transition to a stable 4-wheel mode.There is no other information or data contained in the logs or investigation relevant to the reported event, and no indication of device malfunction.The device behaved as expected.

• 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: 20678488
• Report Number: 3014522447-2024-00001
• Device Sequence Number: 18267514
• 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): 11/13/2024

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: 10/25/2024
• Initial Report FDA Received Date: 11/13/2024
• 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: Hospitalization
• Patient Age: 45 YR
• Patient Sex: Male
• Patient Weight: 75 KG
• Patient Ethnicity: Hispanic
• Patient Race: White