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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device positive airway pressure system
Regulation Description Positive airway pressure delivery system.
Definition A positive airway pressure delivery system is a prescription noninvasive ventilatory device that delivers expiratory positive airway pressure for patients suffering from obstructive sleep apnea. The system also provides positive airway pressure during incipient apnea. The system may include a dedicated flow generator and a patient interface.
Product CodeQBY
Regulation Number 868.5273
Device Class 2

MDR Year MDR Reports MDR Events
2021 1 1
2025 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Patient-Device Incompatibility 1 1
Adverse Event Without Identified Device or Use Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Sleep Dysfunction 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Emotional Changes 1 1
Suicidal Ideation 1 1
Discomfort 1 1
Pain 1 1
Anxiety 1 1
Sexual Dysfunction 1 1
Sensitivity of Teeth 1 1

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