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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device continuous ventilator, minimal ventilatory support
Definition A continuous ventilator (respirator) for emergency use that is intended to provide minimal ventilatory support to mechanically control or assist patient breathing during declared public health emergency.
Product CodeQOR
Device Class Not Classified

MDR Year MDR Reports MDR Events
2022 2 2
2023 4 4
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Pressure Problem 1 1
Energy Output Problem 1 1
Tidal Volume Fluctuations 1 1
Therapeutic or Diagnostic Output Failure 1 1
Contamination 1 1
Contamination /Decontamination Problem 1 1
Patient Device Interaction Problem 1 1
Improper Flow or Infusion 1 1
Infusion or Flow Problem 1 1
Device Emits Odor 1 1
Noise, Audible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 3 3
Unspecified Infection 1 1
Apnea 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Aspiration/Inhalation 1 1
Dyspnea 1 1
Low Oxygen Saturation 1 1

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