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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
Regulation Description Nitric oxide administration apparatus.
Product CodeMRN
Regulation Number 868.5165
Device Class 2


Premarket Reviews
ManufacturerDecision
AIRGAS THERAPEUTICS
  SUBSTANTIALLY EQUIVALENT 1
AIRGAS THERAPEUTICS LLC
  SUBSTANTIALLY EQUIVALENT 1
INTERNATIONAL BIOMEDICAL
  SUBSTANTIALLY EQUIVALENT 1
LINDE GAS & EQUIPMENT INC.
  SUBSTANTIALLY EQUIVALENT 3
MALINCKRODT MANUFACTURING LLC
  SUBSTANTIALLY EQUIVALENT 1
MALLINCKRODT MANUFACTURING LLC
  SUBSTANTIALLY EQUIVALENT 4
PRAXAIR, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 199 199
2021 221 221
2022 115 115
2023 99 99
2024 138 138
2025 12 12

Device Problems MDRs with this Device Problem Events in those MDRs
High Readings 203 203
Failure to Recalibrate 200 200
Intermittent Communication Failure 186 186
Inaccurate Delivery 111 111
Failure to Deliver 106 106
Loose or Intermittent Connection 24 24
Calibration Problem 22 22
Therapeutic or Diagnostic Output Failure 18 18
Device Sensing Problem 15 15
Failure to Calibrate 11 11
Defective Device 9 9
Output Problem 9 9
Excess Flow or Over-Infusion 8 8
Device Displays Incorrect Message 8 8
Incorrect, Inadequate or Imprecise Result or Readings 8 8
Medical Gas Supply Problem 7 7
Device Alarm System 7 7
Break 7 7
Unexpected Shutdown 6 6
Communication or Transmission Problem 6 6
Defective Component 5 5
Adverse Event Without Identified Device or Use Problem 4 4
Protective Measures Problem 4 4
Use of Device Problem 4 4
Battery Problem 4 4
Improper Flow or Infusion 4 4
Infusion or Flow Problem 4 4
Display or Visual Feedback Problem 3 3
Inaccurate Flow Rate 3 3
Complete Loss of Power 2 2
Failure to Sense 2 2
No Flow 2 2
Device-Device Incompatibility 2 2
Inappropriate or Unexpected Reset 2 2
Gas/Air Leak 2 2
Failure to Deliver Shock/Stimulation 2 2
Device Emits Odor 2 2
Insufficient Information 2 2
No Display/Image 2 2
Noise, Audible 2 2
Failure to Charge 2 2
False Alarm 1 1
Insufficient Flow or Under Infusion 1 1
Off-Label Use 1 1
Failure to Auto Stop 1 1
Improper or Incorrect Procedure or Method 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Complete Blockage 1 1
Gas Output Problem 1 1
Product Quality Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 622 622
No Known Impact Or Consequence To Patient 87 87
Low Oxygen Saturation 28 28
Insufficient Information 20 20
No Consequences Or Impact To Patient 13 13
Bradycardia 6 6
Low Blood Pressure/ Hypotension 5 5
Hypoxia 4 4
Tachycardia 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
High Pulmonary Arterial Wedge Pressure 2 2
Irritation 2 2
Cardiac Arrest 2 2
Dyspnea 2 2
Headache 2 2
Nausea 1 1
Underdose 1 1
Malaise 1 1
No Patient Involvement 1 1
Arrhythmia 1 1
Unspecified Respiratory Problem 1 1
Collapse 1 1
Diminished Pulse Pressure 1 1
Loss of consciousness 1 1
Pulmonary Dysfunction 1 1
Death 1 1
Overdose 1 1
Chemical Exposure 1 1
Pulmonary Hypertension 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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