MAUDE manufacturer profile

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · OWB

MAUDE profile for Interventional Fluoroscopic X-Ray System

Key facts

Manufacturer PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Manufacturer group PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Product code OWB
Product code name Interventional Fluoroscopic X-Ray System

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 Clinical Signs, Symptoms or Conditions, Activation Failure, Radiation Output Failure, Positioning Failure, No Display/Image, Insufficient Information, Detachment of Device or Device Component, Unintended System Motion 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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