HVAD Controller Adverse Events: FDA MAUDE Data
Heartware Inc. · Ventricular Assist Device (LVAD) · First cleared Nov 2012 · 2 device variants grouped
Total Reports
360
Reports (30d)
15
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Controller Fault Alarm Due to Battery
backup battery, fault, controller exchanged, use, remains
5
reports
No External Power Alarm During Use
mobile, power unit, external power, mpu, mobile power
3
reports
Power Cable Damage Causing Alarms
vad remains, assist device, ventricular assist, vad, device vad
3
reports
Damaged Controller Cable Nut
backup, controller exchanged, damage, connected, log file
2
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Active safety signals
Evidence
Related research
A Power Tracking Algorithm for Early Detection of Centrifugal Flow Pump Thrombosis.
Slaughter MS, et al. · ASAIO journal (American Society for Artificial Internal Organs : 1992) · 2021
Unexpected Restart Failure of Durable Left Ventricular Assist Devices: A Report of Two Cases.
Seo HW, et al. · Journal of chest surgery · 2024
Two-Year Follow Up of the LATERAL Clinical Trial
Georg Maximilian Wieselthaler, et al. · Circulation Heart Failure · 2021
Third-Generation Continuous-Flow Left Ventricular Assist Devices: A Comparative Outcome Analysis by Device Type
Maks Mihalj, et al. · ESC Heart Failure · 2022
Left Ventricular Assist Device Management in the Emergency Department.
Trinquero P, et al. · The western journal of emergency medicine · 2018
Citations indexed from PubMed.
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