MAUDE manufacturer profile

MASIMO CORPORATION · DQA

MAUDE profile for Oximeter

Key facts

Manufacturer MASIMO CORPORATION
Manufacturer group INDUSTRIAL VALLERA DE MEXICALI, S.A. DE C.V.
Product code DQA
Product code name Oximeter

At a glance

  • 1,000+ MAUDE reports
  • 10–99 Death reports
  • 100–999 Injury reports
  • 1,000+ Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • No Known Impact Or Consequence To Patient, Incorrect Measurement, No Consequences Or Impact To Patient, Display or Visual Feedback Problem, Device Operates Differently Than Expected, Failure To Run On AC/DC, No Patient Involvement, Device Stops Intermittently Most reported problems

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

About MAUDE manufacturer and product code profiles

Manufacturer profiles aggregate MAUDE reports for one manufacturer within one product code, the level at which device safety signals are usually reviewed.

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

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