MAUDE brand profile

CARDIOMEMS PATIENT ELECTRONIC SYSTEM

MAUDE brand safety profile

Key facts

Brand name CARDIOMEMS PATIENT ELECTRONIC SYSTEM

At a glance

  • 1,000+ MAUDE reports
  • 10–99 Injury reports
  • 1,000+ Malfunction reports
  • 10–99 Problems coded
  • 10–99 Problems flagged by Orca1 signal analytics
  • No Clinical Signs, Symptoms or Conditions, Material Frayed, Device Displays Incorrect Message, No Consequences Or Impact To Patient, No Known Impact Or Consequence To Patient, Failure to Power Up, Sparking, Intermittent Loss of Power 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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