MAUDE brand profile

SURELIFE ARM BP MONITORCLASSIC

MAUDE brand safety profile

Key facts

Brand name SURELIFE ARM BP MONITORCLASSIC

At a glance

  • 100–999 MAUDE reports
  • 10–99 Malfunction reports
  • 10–99 Problems coded
  • 10–99 Problems flagged by Orca1 signal analytics
  • No Known Impact Or Consequence To Patient, Device Operational Issue, Device Operates Differently Than Expected, Device Displays Incorrect Message, Incorrect, Inadequate or Imprecise Result or Readings, Output Problem, Incorrect Or Inadequate Test Results, High Test Results 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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