MAUDE manufacturer profile

PHILIPS ULTRASOUND · IYN

MAUDE profile for System, Imaging, Pulsed Doppler, Ultrasonic

Key facts

Manufacturer PHILIPS ULTRASOUND
Manufacturer group PHILIPS ULTRASOUND
Product code IYN
Product code name System, Imaging, Pulsed Doppler, Ultrasonic

At a glance

  • 1,000+ MAUDE reports
  • 10–99 Death reports
  • 10–99 Injury reports
  • 1,000+ Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • No Clinical Signs, Symptoms or Conditions, Unintended System Motion, Material Integrity Problem, Application Program Freezes, Becomes Nonfunctional, Mechanical Jam, No Known Impact Or Consequence To Patient, Patient Data Problem, Electrical /Electronic Property Problem 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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