MAUDE brand profile

HEARTMATE

MAUDE brand safety profile

Key facts

Brand name HEARTMATE

At a glance

  • 100–999 MAUDE reports
  • 10–99 Death reports
  • 10–99 Injury reports
  • 100–999 Malfunction reports
  • 10–99 Problems coded
  • 10–99 Problems flagged by Orca1 signal analytics
  • No Clinical Signs, Symptoms or Conditions, Complete Loss of Power, Use of Device Problem, Electrical Power Problem, Insufficient Information, Disconnection, Mechanical Problem, Device Difficult to Setup or Prepare Most reported problems

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About MAUDE brand safety profiles

Brand profiles aggregate every MAUDE report that names the brand, so you can compare report volumes and problem patterns across devices. Reports are unverified and do not by themselves establish causation.

Source: U.S. Food and Drug Administration (FDA), MAUDE database; aggregation by Orca1

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