MAUDE brand profile

OARM O2

MAUDE brand safety profile

Key facts

Brand name OARM O2

At a glance

  • 10–99 MAUDE reports
  • 10–99 Malfunction reports
  • 10–99 Problems coded
  • 10–99 Problems flagged by Orca1 signal analytics
  • No Patient Involvement, Application Program Freezes, Becomes Nonfunctional, Positioning Problem, No Known Impact Or Consequence To Patient, Communication or Transmission Problem, Noise, Audible, Unintended Electrical Shock, Poor Quality Image 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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