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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
2018 33 33
2019 15 15
2020 35 35
2021 16 16
2022 32 32
2023 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Disconnection 35 35
Material Separation 22 22
Gas/Air Leak 11 11
Loose or Intermittent Connection 9 9
Leak/Splash 8 8
Material Split, Cut or Torn 7 7
Fracture 6 6
Break 4 4
Difficult or Delayed Activation 4 4
Filtration Problem 3 3
Detachment of Device or Device Component 3 3
Fitting Problem 3 3
Tear, Rip or Hole in Device Packaging 3 3
Obstruction of Flow 2 2
Stretched 2 2
Contamination 2 2
Mechanical Problem 2 2
Contamination /Decontamination Problem 2 2
Appropriate Term/Code Not Available 2 2
Patient Device Interaction Problem 1 1
Connection Problem 1 1
Defective Device 1 1
Malposition of Device 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Device Dislodged or Dislocated 1 1
Compatibility Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Deformation 1 1
Material Integrity Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Output Problem 1 1
No Apparent Adverse Event 1 1
Insufficient Information 1 1
Migration or Expulsion of Device 1 1
Nonstandard Device 1 1
No Device Output 1 1
Crack 1 1
Excess Flow or Over-Infusion 1 1
Use of Device Problem 1 1
Suction Problem 1 1
Structural Problem 1 1
Device Damaged Prior to Use 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 55 55
No Clinical Signs, Symptoms or Conditions 36 36
No Known Impact Or Consequence To Patient 16 16
Cardiac Arrest 5 5
Dyspnea 5 5
Insufficient Information 5 5
Foreign Body In Patient 3 3
Respiratory Arrest 3 3
Malaise 2 2
Aspiration/Inhalation 2 2
Hypoxia 2 2
Respiratory Distress 2 2
Low Oxygen Saturation 2 2
No Patient Involvement 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Airway Obstruction 1 1
Foreign Body Reaction 1 1
Hypersensitivity/Allergic reaction 1 1
Ventilator Dependent 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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