MAUDE Adverse Event Report: MOBIUS MOBILITY LLC. IBOT PMD

Model Number IBOT PMD

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Laceration(s) (1946); Concussion (2192)

Event Date 03/12/2022

Event Type  Injury  

Manufacturer Narrative

Mobius mobility investigation: the device involved in the incident was not returned to mobius mobility, however the event logs, fault code data, and black box data were retrieved by the mobius mobility service team.The homeowner's security camera footage was also provided to mobius mobility for review.A failure investigation was performed using the data and video footage.The data from the device shows that 55 seconds after entering stair mode, an event occurred in which the device went into cluster safety lock and exceeded its pitch limit.Cluster safety lock is the device's detection of a loss of pitch control by the user or assistant during stair climbing.Prior to this event, the data shows a portion of step descent with adequate pitch control (braking), then a 5 second period of forward pitch input that causes rapid device movement in the descending direction.The pitch is not adequately controlled by the assistant, resulting in the event.The device data logs are consistent with the reported incident and the user's video.No other alarms were present in the logs that would have contributed to the event.The cause of the incident is most attributed to the assistant's improper foot placement (stance) on the 1st step down from the landing, as shown in the video, which did not allow for proper pitch control of the device.Following the incident, the logs show the device was powered off/on and continued to operate normally with "service required" flag set, which limits device functionality disabling stair mode.This is expected device behavior after the device exceeds its pitch limit.Thus, the device did not malfunction and performed as expected.

Event Description

On 03/29/2022 the user called mobius mobility to report an incident involving the ibot® pmd which occurred on (b)(6) 2022.The user was seated in the ibot® pmd while being assisted down the steps by his wife, who has passed mobius mobility's assisted stair training, and had an event resulting in him being ejected from the device.User stated he was not wearing the provided lap belt at the time of the event as advised in accompanying device labeling.The user reported he sustained a concussion and a laceration on his tongue which required stitches.

• 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: 14118348
• MDR Text Key: 289357452
• Report Number: 3014522447-2022-00001
• 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: 04/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2022
• 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: 03/29/2022
• Was Device Evaluated by Manufacturer?: No
• 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: 51 YR
• Patient Sex: Male
• Patient Weight: 118 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White