Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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
Restricted Flow rate 6 6
Fracture 6 6
Detachment of Device or Device Component 4 4
Difficult or Delayed Activation 4 4
Appropriate Term/Code Not Available 4 4
Fitting Problem 4 4
Mechanical Problem 3 3
Contamination /Decontamination Problem 3 3
Tear, Rip or Hole in Device Packaging 3 3
Filtration Problem 3 3
Split 3 3
Material Deformation 3 3
Material Integrity Problem 2 2
Complete Blockage 2 2
Incorrect Measurement 2 2
No Apparent Adverse Event 2 2
Device Operates Differently Than Expected 2 2
Connection Problem 2 2
Use of Device Problem 2 2
Occlusion Within Device 2 2
Stretched 2 2
Contamination 2 2
Gas Output Problem 2 2
Device Contamination with Chemical or Other Material 1 1
Device Dislodged or Dislocated 1 1
Partial Blockage 1 1
Device Sensing Problem 1 1
Suction Problem 1 1
Nonstandard Device 1 1
Device Inoperable 1 1
Flaked 1 1
Insufficient Flow or Under Infusion 1 1
Excess Flow or Over-Infusion 1 1
Structural Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Moisture or Humidity Problem 1 1
Unsealed Device Packaging 1 1
Defective Component 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Sediment, Precipitate Or Deposit In Device Or Device Ingredient 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
-
-