MAUDE Adverse Event Report: MOBIUS MOBILITY LLC. IBOT PMD

Model Number IBOT PMD

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Fall (1848)

Event Date 07/20/2022

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 297856986
• Report Number: 3014522447-2022-00002
• Device Sequence Number: 1
• Product Code: IMK
• UDI-Device Identifier: 00857584008010
• UDI-Public: 00857584008010
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K210920
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: IBOT PMD
• Device Catalogue Number: MMPX-10000-000
• Device Lot Number: N/A
• Date Manufacturer Received: 07/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/13/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 31 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White