MAUDE Adverse Event Report: MOBIUS MOBILITY LLC. IBOT PMD

Model Number	IBOT PMD
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	11/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
User called indicating he had roll over incident.He said he was going off a curb and was distracted by a car turning the corner and may have taken the curb too quickly, without proper attention, resulting in the tip over.The tip over resulted in 7 stitches.
Additional Manufacturer Narrative
Mobius mobility interviewed the user and retrieved the event/alarm data and black-box data from the device.These data confirm the device entered 4-wheel mode from standard mode on (b)(6) 2024 at 10:30:38.After driving forward on rough terrain (slight oscillation of device and cluster angles) for approx.10 seconds, the device descended a step or curb.The device then pitched forward, lost wheel traction, and rolled to the side.The device recorded a seat brake slip and powerbase alert indicating a controller failure condition due to exceeding its roll limit.The device was subsequently power cycled and recovered with no other relevant information present in the data logs.There is no indication of device malfunction.The likely cause is that the user did not properly align with the curb compounded by too much speed.User manual page 94: "approach obstacles straight on at slow, steady speed.".

• 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: 20780432
• Report Number: 3014522447-2024-00002
• Device Sequence Number: 21090585
• 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): 11/25/2024

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: 11/06/2024
• Initial Report FDA Received Date: 11/26/2024
• 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: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White