MAUDE manufacturer profile

SUNMED HOLDINGS LLC · BTM

MAUDE profile for Ventilator, Emergency, Manual (Resuscitator)

Key facts

Manufacturer SUNMED HOLDINGS LLC
Manufacturer group SUNMED HOLDINGS LLC
Product code BTM
Product code name Ventilator, Emergency, Manual (Resuscitator)

At a glance

  • 100–999 MAUDE reports
  • 10–99 Injury reports
  • 10–99 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • No Known Impact Or Consequence To Patient, Missing Value Reason, Decreased Level of Consciousness, No Clinical Signs, Symptoms or Conditions, Break, Appropriate Term/Code Not Available, Pressure Problem, Appropriate Term / Code Not Available 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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