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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 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Disconnection 37 37
Leak/Splash 32 32
Material Separation 25 25
Defective Device 15 15
Gas/Air Leak 12 12
Loose or Intermittent Connection 10 10
Obstruction of Flow 9 9
Break 8 8
Material Split, Cut or Torn 8 8
Fracture 6 6
Restricted Flow rate 6 6
Difficult or Delayed Activation 4 4
Appropriate Term/Code Not Available 4 4
Detachment of Device or Device Component 4 4
Fitting Problem 4 4
Material Deformation 3 3
Mechanical Problem 3 3
Contamination /Decontamination Problem 3 3
Filtration Problem 3 3
Split 3 3
Tear, Rip or Hole in Device Packaging 3 3
Gas Output Problem 2 2
Material Integrity Problem 2 2
Complete Blockage 2 2
Incorrect Measurement 2 2
No Apparent Adverse Event 2 2
Contamination 2 2
Device Operates Differently Than Expected 2 2
Use of Device Problem 2 2
Connection Problem 2 2
Occlusion Within Device 2 2
Stretched 2 2
Manufacturing, Packaging or Shipping Problem 1 1
Device Damaged Prior to Use 1 1
Unsealed Device Packaging 1 1
Crack 1 1
Migration or Expulsion of Device 1 1
Defective Component 1 1
Device Dislodged or Dislocated 1 1
Nonstandard Device 1 1
Malposition of Device 1 1
Suction Problem 1 1
No Device Output 1 1
Detachment Of Device Component 1 1
Fluid/Blood Leak 1 1
Device Inoperable 1 1
Material Discolored 1 1
Patient Device Interaction Problem 1 1
Deflation Problem 1 1
Insufficient Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 74 74
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 8 8
Dyspnea 7 7
Cardiac Arrest 5 5
Foreign Body In Patient 4 4
Respiratory Arrest 3 3
Aspiration/Inhalation 3 3
Respiratory Distress 2 2
Malaise 2 2
Hypoxia 2 2
Airway Obstruction 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Cyanosis 1 1
High Blood Pressure/ Hypertension 1 1
Hypoventilation 1 1
Hypersensitivity/Allergic reaction 1 1
Diaphoresis 1 1
Missed Dose 1 1
Skin Inflammation/ Irritation 1 1
Foreign Body Reaction 1 1
Discomfort 1 1
Bradycardia 1 1
Anxiety 1 1
Unspecified Respiratory Problem 1 1
Respiratory Insufficiency 1 1
Ventilator Dependent 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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