MAUDE Adverse Event Report: MOBIUS MOBILIYT LLC. IBOT PMD

Model Number IBOT PMD

Device Problems Improper or Incorrect Procedure or Method (2017); Patient Device Interaction Problem (4001); Device Fell (4014)

Patient Problems Fall (1848); Laceration(s) (1946)

Event Date 02/20/2021

Event Type  Injury  

Manufacturer Narrative

The device involved in the incident was brought back to mobius mobility and evaluated.Engineering pulled the electronic logs from the device and found no system failures or issues with the device.The log data captured at the time of the event was evaluated.The data supports that user did not correct the pitch forward command used to transition to the next lower step in stair mode, resulting in the ibot continuing to pitch forward giving the resulting wrench code.Engineering also performed stair climbing test with the device and found it to be functioning normally.From the data and the photos of the stairs that the incident took place on it is believed that the accident was user error.The railing was inadequate for the user to grasp from underneath; the user manual and training manual instruct to grasp the handrail with one hand underneath (palm facing up) and one hand above (palm facing down).

Event Description

User reported a forward fall of the device while attempting to descend a set of stairs in stair mode.On the bottom step, he came down hard and was thrown from the device resulting in a cut on his eyebrow that required stitches.Mobius verified that the user was not wearing his hip belt at the time.

• Brand Name: IBOT PMD
• Type of Device: IBOT
• Manufacturer (Section D): MOBIUS MOBILIYT 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: 11477294
• MDR Text Key: 239577216
• Report Number: 3014522447-2021-00001
• Device Sequence Number: 1
• Product Code: IMK
• UDI-Device Identifier: 00857584008003
• UDI-Public: 00857584008003
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172601
• 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: 03/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2021
• 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: 02/20/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 25 YR