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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device critical care ventilator
Definition A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas during emergency and/or transfer use. Device is intended to be used temporarily and/or in emergency situations during declared public health emergency.
Product CodeQOV
Device Class Not Classified

MDR Year MDR Reports MDR Events
2021 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Gas Output Problem 3 3
Decrease in Pressure 2 2
Reset Problem 2 2
Intermittent Communication Failure 1 1
Failure to Deliver 1 1
No Device Output 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 2 2
No Clinical Signs, Symptoms or Conditions 2 2
Low Oxygen Saturation 1 1

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