MAUDE brand profile

HARMONY LED585 SURGICAL LIGHT

MAUDE brand safety profile

Key facts

Brand name HARMONY LED585 SURGICAL LIGHT

At a glance

  • 10–99 MAUDE reports
  • 1–9 Malfunction reports
  • 10–99 Problems coded
  • 1–9 Problems flagged by Orca1 signal analytics
  • No Known Impact Or Consequence To Patient, Detachment Of Device Component, Failure to Power Up, No Consequences Or Impact To Patient, Component Falling, No Clinical Signs, Symptoms or Conditions, Device Fell, Material Integrity Problem 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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