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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
2020 1 1
2021 8 8
2022 31 31
2023 12 12
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Deliver 29 29
Gas Output Problem 26 26
Decrease in Pressure 24 24
Reset Problem 11 11
Unexpected Shutdown 10 10
Complete Loss of Power 9 9
Use of Device Problem 7 7
Intermittent Communication Failure 5 5
No Flow 3 3
Adverse Event Without Identified Device or Use Problem 3 3
No Apparent Adverse Event 3 3
Mechanical Problem 3 3
Circuit Failure 3 3
No Display/Image 3 3
Obstruction of Flow 3 3
Device Difficult to Program or Calibrate 3 3
Failure to Sense 2 2
Display or Visual Feedback Problem 2 2
Complete Blockage 2 2
Erratic Results 2 2
Insufficient Information 1 1
Data Problem 1 1
Device Handling Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Insufficient Flow or Under Infusion 1 1
Inaccurate Flow Rate 1 1
No Device Output 1 1
Off-Label Use 1 1
Failure to Read Input Signal 1 1
Unexpected Therapeutic Results 1 1
Difficult or Delayed Activation 1 1
Detachment of Device or Device Component 1 1
Gas/Air Leak 1 1
Human-Device Interface Problem 1 1
Infusion or Flow Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 34 34
Insufficient Information 9 9
Low Oxygen Saturation 5 5
Cardiac Arrest 3 3
Respiratory Arrest 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Hypoxia 1 1
No Consequences Or Impact To Patient 1 1
Bronchospasm 1 1
Cough 1 1

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