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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device condenser, heat and moisture (artificial nose)
Product CodeBYD
Regulation Number 868.5375
Device Class 1

MDR Year MDR Reports MDR Events
2019 15 15
2020 35 35
2021 15 15
2022 32 32
2023 45 45
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Disconnection 33 33
Defective Device 14 14
Gas/Air Leak 11 11
Material Separation 9 9
Leak/Splash 9 9
Obstruction of Flow 8 8
Break 7 7
Loose or Intermittent Connection 6 6
Fitting Problem 4 4
Difficult or Delayed Activation 4 4
Appropriate Term/Code Not Available 4 4
Material Split, Cut or Torn 3 3
Tear, Rip or Hole in Device Packaging 3 3
Filtration Problem 3 3
Contamination /Decontamination Problem 2 2
Detachment of Device or Device Component 2 2
Stretched 2 2
Use of Device Problem 2 2
Complete Blockage 2 2
Contamination 2 2
Gas Output Problem 2 2
Incorrect Measurement 2 2
Mechanical Problem 2 2
No Apparent Adverse Event 2 2
Material Deformation 2 2
Material Integrity Problem 1 1
Patient Device Interaction Problem 1 1
Migration or Expulsion of Device 1 1
Nonstandard Device 1 1
No Device Output 1 1
Unsealed Device Packaging 1 1
Excess Flow or Over-Infusion 1 1
Device Damaged Prior to Use 1 1
Defective Component 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Device Sensing Problem 1 1
Device Dislodged or Dislocated 1 1
Malposition of Device 1 1
Patient-Device Incompatibility 1 1
Connection Problem 1 1
Compatibility Problem 1 1
Device Contaminated During Manufacture or Shipping 1 1
Manufacturing, Packaging or Shipping Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 73 73
No Consequences Or Impact To Patient 37 37
Insufficient Information 9 9
Dyspnea 5 5
Cardiac Arrest 4 4
No Known Impact Or Consequence To Patient 4 4
Low Oxygen Saturation 4 4
Respiratory Arrest 3 3
Malaise 2 2
Airway Obstruction 2 2
Aspiration/Inhalation 2 2
No Patient Involvement 2 2
Foreign Body In Patient 2 2
Respiratory Distress 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Cyanosis 1 1
Foreign Body Reaction 1 1
High Blood Pressure/ Hypertension 1 1
Hypoxia 1 1
Ventilator Dependent 1 1
Diaphoresis 1 1
Anxiety 1 1
Discomfort 1 1
Unspecified Respiratory Problem 1 1
Skin Inflammation/ Irritation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 AB ULAX II Oct-06-2020
2 Atos Medical AB II May-10-2021
3 TELEFLEX MEDICAL INC II May-24-2022
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