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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device humidifier nebulizer kit
Regulation Description Respiratory gas humidifier.
Definition This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.
Product CodeOGG
Regulation Number 868.5450
Device Class 2

MDR Year MDR Reports MDR Events
2020 92 96
2021 62 62
2022 14 14
2023 9 9
2024 8 8
2025 11 11

Device Problems MDRs with this Device Problem Events in those MDRs
Gas/Air Leak 41 41
Melted 23 23
Leak/Splash 20 20
Fluid/Blood Leak 17 17
Connection Problem 15 15
Overfill 14 14
Appropriate Term/Code Not Available 11 11
Temperature Problem 8 8
Mechanical Problem 8 8
False Alarm 5 5
Insufficient Information 4 4
Difficult to Open or Close 4 8
Filling Problem 4 4
Infusion or Flow Problem 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Incomplete or Inadequate Connection 2 2
Material Integrity Problem 2 2
Defective Device 2 2
Break 2 2
Improper Flow or Infusion 2 2
Deformation Due to Compressive Stress 1 1
Complete Blockage 1 1
Fire 1 1
Disconnection 1 1
Insufficient Heating 1 1
Partial Blockage 1 1
Fracture 1 1
Overheating of Device 1 1
Material Puncture/Hole 1 1
Device Contamination with Chemical or Other Material 1 1
Burst Container or Vessel 1 1
Loose or Intermittent Connection 1 1
Smoking 1 1
Crack 1 1
Failure to Deliver 1 1
Detachment of Device or Device Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 76 76
No Consequences Or Impact To Patient 52 56
No Patient Involvement 25 25
Low Oxygen Saturation 10 10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 9 9
No Information 8 8
Therapeutic Response, Decreased 7 7
Insufficient Information 6 6
Hypoxia 3 3
No Known Impact Or Consequence To Patient 2 2
Pain 2 2
Thrombosis/Thrombus 1 1
Hematoma 1 1
Anxiety 1 1
Obstruction/Occlusion 1 1
Nasal Obstruction 1 1
Unspecified Respiratory Problem 1 1
Respiratory Distress 1 1
Airway Obstruction 1 1

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