545 - Ventilator Failures for Common Pediatric Home Ventilators: A Food and Drug Administration MAUDE Database Study
Saturday, April 23, 2022
3:30 PM – 6:00 PM US MT
Poster Number: 545 Publication Number: 545.242
Blair Mockler, Seattle Children's, Seattle, WA, United States; Sarah Hofman DeYoung, Seattle Children's/University of Washington School of Medicine, Seattle, WA, United States; Ashley Han, Seattle Children's Hospital, Seattle, WA, United States; Randall A. Bly, Seattle Children's Hospital, University of Washington, Seattle, WA, United States; Leslie M. Elder, Seattle Children's Hospital, Enumclaw, WA, United States; Kelly N. Evans, University of Washington, Seattle, WA, United States; Amanda Striegl, Seattle Children's, Seattle, WA, United States; Thida Ong, Seattle Children's Hospital/University of Washington, Seattle, WA, United States
Pediatric Resident Seattle Children's Hospital, University of Washington Seattle, Washington, United States
Background: Tracheostomy-associated mortality is high, ranging from 1%-8%. Tracheostomy-dependent children (TDC) receiving home mechanical ventilation (HMV) may be more at risk of safety events. In prior safety screening in an HMV clinic, we found 58% of 202 TDC reported events involving home equipment. However, gaps remain to understand the prevalence and preventable sources of these events.
Objective: The FDA’s Manufacturer and User Facility Device Experience (MAUDE) database is composed of durable medical equipment (DME) reports from manufacturers, health care workers, and patients. Although this database also includes reports from adults and non-invasive uses, our objective was to describe reported events among the 3 most common home ventilator models for TDC discharged from Seattle Children’s Hospital (SCH).
Design/Methods: We queried the MAUDE database, recording incident reports for 3 ventilator models (Trilogy 100, Trilogy 200, Astral 150) commonly used for home care in our TDC population between January 2021 and December 2021. We categorized 5 event types (issues with air delivery, power source, sensor error, hardware/software, user interface) based on descriptive comments submitted to the MAUDE database.
Results: We identified 2803 ventilator event reports (Astral 150: 1358; Trilogy 100: 1372; Trilogy 200:73). Battery or power source errors were the most common event (827;30%). Other events reported included: air delivery problems (614;25%), hardware and software (423;15%), user interface problems (261;9%), sensor problems (199;7%). Among the reports reviewed by the manufacturer, a cause could not be assessed by the manufacturer in 277 instances, and 84 ventilators were found to be functioning without issue by the manufacturer.Conclusion(s): Using a large publicly available database, our study reveals that in 2021 a high number of events commonly occurred in ventilators used by children at SCH requiring HMV. The high proportion of reports involving ventilator power supply and air delivery strongly suggest that children dependent on HMV for life-sustaining care at home may be at the highest risk for harm from ventilator failures. These events highlight the need for essential backup DME, including ventilators to prevent harm. Acuity is likely higher among TDC with HMV dependence, informing the need for updated pediatric homecare policies and training. Policy changes supporting adequate supply of backup equipment and empowerment of caregivers to maintain and fight for quality DME may protect TDC from preventable harm caused by equipment failures at home. Blair Mockler CVBM CV_1:7:22.pdf