Heartware Inc. · Ventricular Assist Device (LVAD)
Total Reports
220
Reports (30d)
219
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Cardiac Arrhythmia Requiring Intervention
data registry, report event, registry does, device vad, reported intermacs
47
reports
Fluid Overload Hospitalization
data registry, event event, contain device, device vad, possible information
28
reports
Bacterial Bloodstream Infection Treatment
data registry, correlated previously, device identifying, device vad, likely available
17
reports
Driveline Infection Requiring IV Treatment
data registry, information likely, device analysis, device vad, possible information
16
reports
Major Upper Gastrointestinal Bleed
data registry, event event, gastrointestinal, bleed, device vad
13
reports
Gastrointestinal Bleed Hospitalization
data registry, patient complications, gastrointestinal, bleed, device vad
11
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
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Claripulse monitors these devices weekly and detects anomalies using 6 statistical methods — spike, trend, changepoint, peer-outlier, and more. 1 active signal detected right now.
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