A review of hospital based ventilator malfunctions reported to the FDA in 2021

Stephen Tunnell

Abstract

Ventilator care is synonymous with Intensive care. These devices are electromechanical and as such can fail. Most failures are without patient incident, injury, and harm.

The FDA requires manufacturers who learn of malfunction, injury or death while operating their product to report to the agency via the Manufacturer and User Facility Device Experience database.

I reviewed 500 recent events reported to the FDA and found an increasing trend from 2020 to 2021 in hospital ventilator malfunction reports. Examination of these reports is critical to assuring quality ventilator care.

The author concluded that intensive training on the device characteristics and feature and a more rigorous examination of ventilator performance between patients may assist in reducing device malfunctions.

Keywords

Mechanical ventilation, Ventilator malfunction, FDA

References

1. Total Product Lifecycle database: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTPLC/tplc.cfm

2. MAUDE database: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Search.cfm

3. American Hospital Association – Fast facts: https://www.aha.org/statistics/fast-facts-us-hospitals

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