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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
INTERNATIONAL BIOMEDICAL
  SUBSTANTIALLY EQUIVALENT 1
LINDE GAS & EQUIPMENT INC.
  SUBSTANTIALLY EQUIVALENT 1
MALLINCKRODT MANUFACTURING LLC
  SUBSTANTIALLY EQUIVALENT 2
PRAXAIR DISTRIBUTION, INC
  SUBSTANTIALLY EQUIVALENT 1
PRAXAIR, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 138 138
2019 144 144
2020 199 199
2021 221 221
2022 115 115
2023 48 48

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Deliver 161 161
Inaccurate Delivery 136 136
High Readings 134 134
Intermittent Communication Failure 133 133
Failure to Recalibrate 131 131
Device Displays Incorrect Message 75 75
Calibration Problem 40 40
Failure to Calibrate 39 39
Excess Flow or Over-Infusion 39 39
Device Alarm System 32 32
Therapeutic or Diagnostic Output Failure 32 32
Break 22 22
Device Operates Differently Than Expected 17 17
Defective Device 17 17
Device Sensing Problem 16 16
Loose or Intermittent Connection 16 16
Protective Measures Problem 14 14
Incorrect, Inadequate or Imprecise Result or Readings 11 11
Battery Problem 11 11
Output Problem 10 10
Defective Component 9 9
Display or Visual Feedback Problem 8 8
Appropriate Term/Code Not Available 8 8
Improper Flow or Infusion 7 7
Medical Gas Supply Problem 7 7
No Flow 6 6
Structural Problem 6 6
Communication or Transmission Problem 6 6
Inaccurate Flow Rate 6 6
Unexpected Shutdown 5 5
Failure to Sense 4 4
Adverse Event Without Identified Device or Use Problem 4 4
Infusion or Flow Problem 4 4
Power Problem 3 3
High Test Results 3 3
Use of Device Problem 3 3
Failure to Deliver Shock/Stimulation 3 3
Electrical /Electronic Property Problem 2 2
Calibration Error 2 2
No Audible Alarm 2 2
Device Emits Odor 2 2
Loss of Power 2 2
Low Battery 2 2
Insufficient Flow or Under Infusion 2 2
Charging Problem 2 2
Noise, Audible 2 2
Complete Loss of Power 1 1
Delivery System Failure 1 1
Failure to Auto Stop 1 1
Gas/Air Leak 1 1
Device Damaged by Another Device 1 1
Application Program Problem 1 1
Pressure Problem 1 1
Positioning Problem 1 1
Temperature Problem 1 1
Insufficient Information 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Inadequate Instructions for Non-Healthcare Professional 1 1
Output below Specifications 1 1
Off-Label Use 1 1
Product Quality Problem 1 1
Unable to Obtain Readings 1 1
Inadequate Service 1 1
Device Inoperable 1 1
Output above Specifications 1 1
Power Conditioning Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Incorrect Or Inadequate Test Results 1 1
Alarm Not Visible 1 1
Signal Artifact/Noise 1 1
False Alarm 1 1
Low Audible Alarm 1 1
Circuit Failure 1 1
Complete Blockage 1 1
No Display/Image 1 1
Fluid/Blood Leak 1 1
Gas Output Problem 1 1
Migration or Expulsion of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 435 435
No Known Impact Or Consequence To Patient 254 254
No Consequences Or Impact To Patient 67 67
No Patient Involvement 52 52
Low Oxygen Saturation 21 21
Insufficient Information 19 19
No Information 9 9
Bradycardia 4 4
Low Blood Pressure/ Hypotension 3 3
Hypoxia 3 3
Irritation 2 2
Dyspnea 2 2
Headache 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Tachycardia 2 2
Arrhythmia 1 1
Pulmonary Hypertension 1 1
Unspecified Respiratory Problem 1 1
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

Recalls
Manufacturer Recall Class Date Posted
1 INO therapeutics LLC/dba ikaria II Aug-08-2018
2 Mallinckrodt, LLC. II Sep-13-2022
3 Vero Biotech, LLC I Sep-30-2021
4 Vero Biotech, LLC I Jun-23-2021
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