HVAD Controller Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · Ventricular Assist Device (LVAD) · First cleared Nov 2012
Total Reports
3,943
Reports (30d)
12
Active Signals
0
Open Recalls
69
What the reports describe · Claripulse analysis
Most commonly reported problems
Controller Fault from Battery End of Life
battery, controller exchanged, use, fault alarm, remains
13
reports
Motor Start Event with Low Flow Alarms
vad, complications, use, device vad, vad remains
2
reports
Controller Fault Alarm with Exchange
non, captured, controller exchanged, issues, fault alarm
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Regulatory
FDA recalls for this device
Oct 31, 2023 · Open, Classified
Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm may sound and the recommended troubleshooting actions and (2) instructions relating to the useful life of the HVAD system components
Oct 31, 2023 · Open, Classified
Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm may sound and the recommended troubleshooting actions and (2) instructions relating to the useful life of the HVAD system components
Oct 31, 2023 · Open, Classified
Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm may sound and the recommended troubleshooting actions and (2) instructions relating to the useful life of the HVAD system components
Oct 31, 2023 · Open, Classified
Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm may sound and the recommended troubleshooting actions and (2) instructions relating to the useful life of the HVAD system components
Oct 31, 2023 · Open, Classified
Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm may sound and the recommended troubleshooting actions and (2) instructions relating to the useful life of the HVAD system components
Oct 31, 2023 · Open, Classified
Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm may sound and the recommended troubleshooting actions and (2) instructions relating to the useful life of the HVAD system components
Evidence
Related research
Long-term assist device patients admitted to ICU: Tips and pitfalls
Michiel Morshuis, et al. · Journal of Intensive Medicine · 2022
Hemodynamic exercise responses with a continuous-flow left ventricular assist device: Comparison of patients’ response and cardiorespiratory simulations
Christoph Gross, et al. · PLoS ONE · 2020
Citations indexed from PubMed.
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