MAUDE manufacturer profile

PHILIPS MEDICAL SYSTEMS · DSI

MAUDE profile for Detector And Alarm, Arrhythmia

Key facts

Manufacturer PHILIPS MEDICAL SYSTEMS
Manufacturer group PHILIPS MEDICAL SYSTEMS
Product code DSI
Product code name Detector And Alarm, Arrhythmia

At a glance

  • 1,000+ MAUDE reports
  • 100–999 Death reports
  • 100–999 Injury reports
  • 1,000+ Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • No Audible Alarm, No Patient Involvement, No Known Impact Or Consequence To Patient, No Clinical Signs, Symptoms or Conditions, No Audible Prompt/Feedback, Device Operates Differently Than Expected, No Device Output, Device Displays Incorrect Message 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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