MAUDE manufacturer profile

INVIVO, A DIVISION OF PHILIPS MEDICAL SYSTEMS · MWI

MAUDE profile for Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

Key facts

Manufacturer INVIVO, A DIVISION OF PHILIPS MEDICAL SYSTEMS
Manufacturer group INVIVO, A DIVISION OF PHILIPS MEDICAL SYSTEMS
Product code MWI
Product code name Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

At a glance

  • 100–999 MAUDE reports
  • 1–9 Death reports
  • 10–99 Injury reports
  • 100–999 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • No Clinical Signs, Symptoms or Conditions, Incorrect, Inadequate or Imprecise Result or Readings, Incorrect Measurement, Application Program Freezes, Becomes Nonfunctional, Insufficient Information, No Audible Alarm, Computer Software Problem, Defibrillation/Stimulation 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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