MAUDE manufacturer profile

GE HEALTHCARE · MHX

MAUDE profile for Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

Key facts

Manufacturer GE HEALTHCARE
Manufacturer group GE HEALTHCARE
Product code MHX
Product code name Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

At a glance

  • 100–999 MAUDE reports
  • 10–99 Death reports
  • 10–99 Injury reports
  • 100–999 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • No Known Impact Or Consequence To Patient, Device Operates Differently Than Expected, No Consequences Or Impact To Patient, Device Alarm System, No Patient Involvement, No Information, False Reading From Device Non-Compliance, Failure to Read Input Signal 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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