MAUDE Adverse Event Report: MOBIUS MOBILITY LLC. IBOT PMD

Model Number	IBOT PMD
Health Effect - Clinical Code	Fall (1848)
Date of Event	07/20/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Mobius mobility investigation: device was returned to mobius mobility.Black box and event logs were retrieved, and the device electronics and systems were functioning as expected.The data was consistent with loss of control of the ibot while descending the stairs.The attendant handle had been removed for transit in a small car, and it was not fully and properly reinstalled with all the required parts.This would make it possible for the attendant handle to slide out if it was not latched in place.Images of the device just prior to the incident show that the handle was not in a latched position.The lack of correct installation and the handle not being in the latched position for stair climbing resulted in the handle detachment.
Event or Problem Description
During an assisted stair climbing demonstration on (b)(6) 2022, the attendant handle used for stair climbing came detached resulting in the person in the ibot falling down several steps.The device occupant was not seriously injured.

• 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 ; 6034258703
• MDR Report Key: 15220467
• Report Number: 3014522447-2022-00002
• Device Sequence Number: 17595401
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/12/2022

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: 07/20/2022
• Initial Report FDA Received Date: 08/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/13/2020
• 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: 31 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White