MAUDE manufacturer profile

ST. JUDE MEDICAL · DQK

MAUDE profile for Computer, Diagnostic, Programmable

Key facts

Manufacturer ST. JUDE MEDICAL
Manufacturer group ST. JUDE MEDICAL, INC.
Product code DQK
Product code name Computer, Diagnostic, Programmable

At a glance

  • 1,000+ MAUDE reports
  • 1–9 Death reports
  • 100–999 Injury reports
  • 100–999 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • No Clinical Signs, Symptoms or Conditions, Communication or Transmission Problem, No Consequences Or Impact To Patient, Display or Visual Feedback Problem, Output Problem, Signal Artifact/Noise, Failure of Device to Self-Test, Failure to Power Up 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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