Rehabilitation Engineering Design Laboratory

RED LAB

AWARE

Adverse Wheelchair Events REgistry (AWaRE) introduce a framework that analyze FDA adverse event reports related to manual and powered wheelchairs through event statistics and trends, device failures and malfunction patterns.

AWARE

Context

Manual and powered wheelchairs are critical mobility devices that support independence, accessibility, and quality of life for millions of individuals with mobility impairments. Given their widespread use, device safety and reliability are essential to minimizing the risk of user injury, adverse health outcomes, and disruptions to daily living. The U.S. Food and Drug Administration (FDA) collects adverse event reports through systems such as the Manufacturer and User Facility Device Experience (MAUDE) database, which contains reports of device-related injuries, malfunctions, deaths, and other safety concerns.

Objective

The objective of this project is to analyze FDA adverse event reports associated with manual and powered wheelchairs to identify common factors contributing to reported safety events. Specifically, the analysis will inform the development a comprehensive understanding of the most common and impactful factors associated with wheelchair-related adverse events, taking a form of a digital platform enabling stakeholders to prioritize interventions that improve wheelchair safety, reliability, and user outcomes.

Contact

Dr. Anand Mhatre for more information.

Death Event Flow: Wheelchair Users

Fifty reported deaths traced from wheelchair group, through the root cause and device problem identified in the report, to the patient-level problem and final outcome. Hover any node or link to trace its path!

01 Wheelchair Group 02 Root Cause 03 Device Problem 04 Patient Problem 05 End Outcome

Our Team

Anand Mhatre

PhD
Project Director & Principal Investigator

Carmen DiGiovine

PhD, ATP/SMS, RET
Co-Investigator

Kayden Gill

OTD
Physical Therapist

Kamila Nieto

Undergraduate
Student Researcher