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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device nebulizer, medicinal, non-ventilatory (atomizer)
Regulation Description Medicinal nonventilatory nebulizer (atomizer).
Product CodeCCQ
Regulation Number 868.5640
Device Class 1

MDR Year MDR Reports MDR Events
2020 1 1
2021 2 2
2023 7 7
2024 7 7
2025 30 30

Device Problems MDRs with this Device Problem Events in those MDRs
Material Discolored 6 6
Insufficient Flow or Under Infusion 6 6
Complete Blockage 5 5
Patient Device Interaction Problem 5 5
Loose or Intermittent Connection 5 5
Break 4 4
Unsealed Device Packaging 3 3
Product Quality Problem 3 3
Disconnection 2 2
Device Markings/Labelling Problem 2 2
Contamination /Decontamination Problem 2 2
Failure to Power Up 2 2
Material Separation 2 2
Lack of Maintenance Documentation or Guidelines 2 2
Output Problem 1 1
Suction Failure 1 1
Defective Device 1 1
Inadequate Instructions for Healthcare Professional 1 1
No Pressure 1 1
Component Missing 1 1
Infusion or Flow Problem 1 1
Delivered as Unsterile Product 1 1
Detachment of Device or Device Component 1 1
Human-Device Interface Problem 1 1
Self-Activation or Keying 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 37 37
Insufficient Information 8 8
Laceration(s) 1 1
No Consequences Or Impact To Patient 1 1
Hemorrhage/Bleeding 1 1

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