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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
2014 6 6
2015 17 17
2016 18 18
2017 12 12
2018 33 33
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 37 37
Leak/Splash 32 32
Material Separation 24 24
Defective Device 15 15
Gas/Air Leak 11 11
Loose or Intermittent Connection 10 10
Obstruction of Flow 9 9
Break 8 8
Material Split, Cut or Torn 7 7
Restricted Flow rate 6 6
Fracture 6 6
Difficult or Delayed Activation 4 4
Fitting Problem 4 4
Appropriate Term/Code Not Available 4 4
Detachment of Device or Device Component 4 4
Contamination /Decontamination Problem 3 3
Filtration Problem 3 3
Material Deformation 3 3
Split 3 3
Tear, Rip or Hole in Device Packaging 3 3
Use of Device Problem 2 2
Stretched 2 2
Occlusion Within Device 2 2
Gas Output Problem 2 2
Incorrect Measurement 2 2
Mechanical Problem 2 2
Complete Blockage 2 2
Contamination 2 2
Material Integrity Problem 2 2
Device Operates Differently Than Expected 2 2
Connection Problem 2 2
No Apparent Adverse Event 2 2
Insufficient Information 1 1
Patient Device Interaction Problem 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Device Sensing Problem 1 1
Device Dislodged or Dislocated 1 1
Device Contamination with Chemical or Other Material 1 1
Moisture or Humidity Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Pressure Problem 1 1
Sediment, Precipitate Or Deposit In Device Or Device Ingredient 1 1
Compatibility Problem 1 1
Device Contaminated During Manufacture or Shipping 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Crack 1 1
Deflation Problem 1 1
Material Discolored 1 1
Detachment Of Device Component 1 1
Flaked 1 1
Migration or Expulsion of Device 1 1
Nonstandard Device 1 1
Excess Flow or Over-Infusion 1 1
Material Fragmentation 1 1
No Device Output 1 1
Unsealed Device Packaging 1 1
Device Inoperable 1 1
Suction Problem 1 1
Insufficient Flow or Under Infusion 1 1
Device Damaged Prior to Use 1 1
Defective Component 1 1
Partial Blockage 1 1
Structural Problem 1 1
Malposition of Device 1 1
Patient-Device Incompatibility 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 65 65
No Known Impact Or Consequence To Patient 33 33
No Patient Involvement 20 20
Insufficient Information 9 9
No Information 8 8
Low Oxygen Saturation 7 7
Dyspnea 7 7
Cardiac Arrest 5 5
Foreign Body In Patient 4 4
Respiratory Arrest 3 3
Aspiration/Inhalation 3 3
Malaise 2 2
Hypoxia 2 2
Respiratory Distress 2 2
Airway Obstruction 2 2
Unspecified Respiratory Problem 1 1
Skin Inflammation/ Irritation 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Anxiety 1 1
Discomfort 1 1
Ventilator Dependent 1 1
Diaphoresis 1 1
Missed Dose 1 1
Bradycardia 1 1
Cyanosis 1 1
Foreign Body Reaction 1 1
Hypersensitivity/Allergic reaction 1 1
High Blood Pressure/ Hypertension 1 1
Hypoventilation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 AB ULAX II Oct-06-2020
2 Arc Medical Inc III May-09-2015
3 Atos Medical AB II May-10-2021
4 TELEFLEX MEDICAL INC II May-24-2022
5 Teleflex Medical II Aug-29-2016
6 Teleflex Medical II Aug-09-2016
7 Teleflex Medical I Feb-06-2015
8 Teleflex, Inc. I Feb-06-2015
9 Vital Signs Devices, a GE Healthcare Company I Jul-30-2011
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