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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device apparatus, nitric oxide delivery
Product CodeMRN
Regulation Number 868.5165
Device Class 2


Premarket Reviews
ManufacturerDecision
AIRGAS THERAPEUTICS
  SUBSTANTIALLY EQUIVALENT 1
INTERNATIONAL BIOMEDICAL
  SUBSTANTIALLY EQUIVALENT 1
LINDE GAS & EQUIPMENT INC.
  SUBSTANTIALLY EQUIVALENT 2
MALLINCKRODT MANUFACTURING LLC
  SUBSTANTIALLY EQUIVALENT 3
PRAXAIR, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 144 144
2020 199 199
2021 221 221
2022 115 115
2023 99 99
2024 30 30

Device Problems MDRs with this Device Problem Events in those MDRs
High Readings 168 168
Failure to Recalibrate 165 165
Intermittent Communication Failure 160 160
Inaccurate Delivery 133 133
Failure to Deliver 113 113
Calibration Problem 34 34
Therapeutic or Diagnostic Output Failure 32 32
Device Alarm System 28 28
Failure to Calibrate 27 27
Device Displays Incorrect Message 23 23
Excess Flow or Over-Infusion 21 21
Loose or Intermittent Connection 20 20
Device Sensing Problem 15 15
Protective Measures Problem 14 14
Defective Device 14 14
Break 12 12
Incorrect, Inadequate or Imprecise Result or Readings 11 11
Output Problem 10 10
Medical Gas Supply Problem 7 7
Defective Component 7 7
Display or Visual Feedback Problem 7 7
Inaccurate Flow Rate 6 6
No Flow 6 6
Communication or Transmission Problem 6 6
Unexpected Shutdown 5 5
Appropriate Term/Code Not Available 5 5
Infusion or Flow Problem 5 5
Battery Problem 5 5
Improper Flow or Infusion 4 4
Adverse Event Without Identified Device or Use Problem 4 4
Use of Device Problem 4 4
Failure to Sense 3 3
Failure to Deliver Shock/Stimulation 3 3
Device Emits Odor 2 2
Loss of Power 2 2
Insufficient Flow or Under Infusion 2 2
High Test Results 2 2
Power Problem 2 2
Charging Problem 2 2
Noise, Audible 2 2
Complete Loss of Power 1 1
Temperature Problem 1 1
Insufficient Information 1 1
Device-Device Incompatibility 1 1
Failure to Auto Stop 1 1
Gas/Air Leak 1 1
Pressure Problem 1 1
Inadequate Instructions for Non-Healthcare Professional 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Application Program Problem 1 1
Precipitate in Device or Device Ingredient 1 1
Off-Label Use 1 1
Product Quality Problem 1 1
Unable to Obtain Readings 1 1
Improper or Incorrect Procedure or Method 1 1
Output above Specifications 1 1
Fluid/Blood Leak 1 1
Gas Output Problem 1 1
Electrical /Electronic Property Problem 1 1
No Display/Image 1 1
Circuit Failure 1 1
Complete Blockage 1 1
False Alarm 1 1
Low Audible Alarm 1 1
No Audible Alarm 1 1
Signal Artifact/Noise 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 511 511
No Known Impact Or Consequence To Patient 182 182
No Consequences Or Impact To Patient 37 37
No Patient Involvement 24 24
Low Oxygen Saturation 23 23
Insufficient Information 19 19
Bradycardia 6 6
Hypoxia 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Low Blood Pressure/ Hypotension 3 3
Tachycardia 2 2
No Information 2 2
Irritation 2 2
Dyspnea 2 2
Headache 2 2
Cardiac Arrest 1 1
Death 1 1
Nausea 1 1
Overdose 1 1
Pulmonary Dysfunction 1 1
High Pulmonary Arterial Wedge Pressure 1 1
Underdose 1 1
Chemical Exposure 1 1
Diminished Pulse Pressure 1 1
Malaise 1 1
Collapse 1 1
Loss of consciousness 1 1
Pulmonary Hypertension 1 1
Unspecified Respiratory Problem 1 1
Arrhythmia 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Mallinckrodt, LLC. II Sep-13-2022
2 NOXBOX LTD I Jun-09-2023
3 Vero Biotech, LLC II Dec-15-2023
4 Vero Biotech, LLC I Sep-30-2021
5 Vero Biotech, LLC I Jun-23-2021
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