MAUDE manufacturer profile

SANMINA -SCI SYSTEMS · OWB

MAUDE profile for Interventional Fluoroscopic X-Ray System

Key facts

Manufacturer SANMINA -SCI SYSTEMS
Manufacturer group SANMINA -SCI SYSTEMS
Product code OWB
Product code name Interventional Fluoroscopic X-Ray System

At a glance

  • 1,000+ MAUDE reports
  • 1–9 Death reports
  • 10–99 Injury reports
  • 1,000+ Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • No Clinical Signs, Symptoms or Conditions, Application Program Freezes, Becomes Nonfunctional, Radiation Output Failure, Positioning Problem, No Patient Involvement, Failure to Advance, Device Sensing Problem, Noise, Audible 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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