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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device ventilatory assistance helmet
Definition Patient interface for delivery of positive pressure to assist patient's breathing during declared public health emergency. Can be used with continuous and non-continuous ventilators, wall gas source, oxygen source, humidified gases.
Product CodeQOW
Device Class Not Classified

MDR Year MDR Reports MDR Events
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Use of Device Problem 1 1
Pressure Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1 1

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