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	Limb Fracture (4518)
Date of Event	01/20/2023
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• 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: 16886448
• Report Number: 3014522447-2023-00001
• Device Sequence Number: 6174231
• 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): 05/08/2023

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