MAUDE Adverse Event Report: MOBIUS MOBILITY LLC. IBOT PMD

Model Number IBOT PMD

Device Problem Off-Label Use (1494)

Patient Problem Limb Fracture (4518)

Event Date 01/20/2023

Event Type  Injury  

Manufacturer Narrative

The user contacted mobius shortly after the event, as the fall resulted in a remote code appearing on the ibot.This is expected device behavior in the event of a fall.The user, who was not yet aware of the injury, reported to mobius staff that no injury had occurred.Mobius staff cleared the code remotely.At a later date, the user contacted mobius for a service request unrelated to this incident.At that time, he mentioned in passing having broken a leg when he caught a wheel and fell while in balance mode on a cruise ship.Mobius staff confirmed with him that this was the same event for which he had previously reported no injury.Mobius retrieved the logs from his device.No device malfunction was indicated in the logs.Assessment of the logs corroborated the user's account that a fall had occurred, and indicated that the fall was due to user error.The user manual warnings state to "avoid obstacles, slick surfaces, or excessive rocking when in balance mode.".

Event Description

The user reported being in balance mode on a cruise ship, and catching a wheel on something, causing the device to go over sideways.This resulted in the user breaking their leg, which, due to their medical condition, they did not feel and therefore did not realize at the time that they had sustained an injury.

• 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: 16886448
• MDR Text Key: 314739803
• Report Number: 3014522447-2023-00001
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2023
• 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: 04/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2022
• 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: 57 YR
• Patient Sex: Male
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White