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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

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

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 2 2
No Clinical Signs, Symptoms or Conditions 1 1
Apnea 1 1
Aspiration/Inhalation 1 1
Dyspnea 1 1
Unspecified Infection 1 1
Low Oxygen Saturation 1 1

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