MAUDE Adverse Event Report: MOBIUS MOBILITY LLC. IBOT PMD

Model Number IBOT PMD

Device Problem Off-Label Use (1494)

Patient Problem Hip Fracture (2349)

Event Date 05/31/2023

Event Type  Injury  

Manufacturer Narrative

The action of the user and spouse was an attempt to rotate the clusters in order to switch the position of the two sets of drive wheels and thus try to ensure even tire wear.Stair mode is only intended for use on stairs.Per the user manual, "the device does not balance itself during stair climbing".This is covered in the certificate training program for the user and the assistant during stair climbing.If stair mode is initiated on level ground without steps, and the device is pulled backward, the device tipping and falling over is expected behavior.The initial report from the user stated his spouse only sustained a bruised hip.Upon further discussion with the user five days after the initial report, he clarified that his spouse broke her pelvis as a result of the event.Mobius retrieved the logs from the 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.

Event Description

User initiated stair mode on level ground without steps and had his spouse pull back on the device.This resulted in the device falling over backward onto her, breaking her pelvis.

• 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: 17175129
• MDR Text Key: 317636520
• Report Number: 3014522447-2023-00002
• 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: 06/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2023
• 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: 06/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2020
• 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: 73 YR
• Patient Sex: Female
• Patient Weight: 59 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White